Investigator-Initiated Studies

Investigator-Initiated Studies is sponsored by AbbVie. AbbVie supports investigator-initiated studies across various therapeutic areas. While not explicitly microbiome-focused, infectious diseases are a relevant area for pharmaceutical companies.

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Investigator-Initiated Studies # Investigator-Initiated Studies We’re committed to supporting investigator-initiated research that promotes the advancement of medical and scientific knowledge involving AbbVie’s products and therapeutic areas of interest.

## Advancing science through investigator-sponsored research The research from Investigator-Initiated Studies (IIS) has the capability to expand understanding of our products and their potential applications. Plus, data from investigator-sponsored research can inform patient care and spark new ideas for further disease-related research.

The AbbVie IIS Program provides an opportunity for academic and community-based physicians and researchers worldwide interested in conducting their own research to apply for research support. If you’re an investigator, you can initiate the application process by submitting a brief summary of the proposed research for AbbVie associated products through the:IIS Study Submission Portal.

IIS applications are accepted on a rolling submission basis. Following the review of the initial submission, you may be asked to submit a full protocol and final study budget for further evaluation. Submission of a proposal does not imply or guarantee approval.

The committee evaluates proposals according to scientific merit, alignment with our areas of research interest and available funding. Financial and/or product support is contingent upon full execution of the research agreement by both parties. ## Therapeutic areas of interest Please refer to the below Therapeutic Areas to learn more about our 2026 IIS strategic priorities: CoolSculpting® Elite, CoolTone® Body Contouring Portfolio** 1.

To assess the impact of different treatment regimens to understand factors that optimize patient selection, treatment and patient satisfaction. 2. To explore novel indications or use including treatment in broad demographic patient populations.

**Things to consider for the investigator:** * Limited funds may be available to support proposals.

* Studies will only be initiated for compounds that have received regulatory approval for at least one indication in the country of interest Neurotoxins (e.g. Botox/Vistabel), Fillers (e.g. Juvéderm, Vycross,Hylacross), HArmonyCa Hybrid Filler, Pan Facial** * Benefits of the Allergan Aesthetics portfolio, either alone or in combination with other modalities, including achieving facial harmony/balance, enhancing skin quality, and/or improving patient/observer reported outcomes in broad demographic patient populations.

* Benefit of adherence to a long-term treatment plan with the Allergan Aesthetics portfolio of products. * Efficacy, safety, and psychosocial impact of simultaneous treatment of multiple areas with labelled dosage of Botox® including over repeat treatment cycles. * The importance of patient selection in delivering optimal outcomes (right patient/right product).

* Correlation of rheologic/physiochemical properties with the clinical benefit/impact of treatments. * Innovative ways to objectively measure and track clinical efficacy of treatment. * Impact of individual treatment on skin architecture/skin quality.

* Novel aesthetic uses of Allergan Aesthetic products. * The use of Allergan Aesthetics’ portfolio as part of a treatment plan in individuals who have undergone medical weight loss.

**Things to consider for the investigator:** * Limited funds may be available to support proposals * Studies will only be initiated for compounds that have received regulatory approval for at least one indication in the country of interest **PLASTICS AND REGENERATIVE MEDICINE: Breast Implants, Acellular Dermal Matrices (ADMs), Fat Grafting** **Breast Implant Portfolio Enhancing scientific knowledge to improve clinical outcomes:** * Immediate & long-term patient outcomes with Natrelle Inspira smooth implants and tissue expanders.

* GLP-1 weight loss and breast augmentation * Systemic symptoms reported by patients with breast implants (SSBI): etiology, pathogenesis, epidemiology, and management. * BIA-ALCL/rare malignancies that have been reported in breast implant capsules: mitigation, etiology, pathogenesis, epidemiology, and treatments.

**Supporting best practice techniques:** * Infection control techniques to improve patient outcomes (e.g. Keller funnel, aseptic technique) * Keller funnel clinical outcomes measures * Patient/implant matching for optimal outcomes (e.g., cohesivity matching) * Global best practice surgical techniques to optimize outcomes with Allergan Aesthetics Breast Implant portfolio.

* Using Allergan Aesthetics plastic surgical products in combination to address clinical needs and optimize patient outcomes. **Regenerative Medicine Portfolio Acellular Dermal Matrix Portfolio (Artia, Alloderm and Strattice):** * Data evaluating integration of ADM using histology and/or outcomes measures. * Short- and long-term patient outcomes using Allergan Aesthetic ADMs for patients requiring soft tissue reinforcement or repair.

* Best practice surgical technique considerations to enhance patient outcomes. * Data evaluating radiation therapy risks of complications, impact on tissue healing, and aesthetic outcomes with ADMs. * Data evaluating fat grafting outcomes and fat retention with ADMs.

* Advance the understanding of surgical and patient outcomes using Revolve including patient/surgeon satisfaction, time savings and graft retention. **Things to consider for the investigator:** * Limited funds may be available to support proposals.

* Studies will only be initiated for compounds that have received regulatory approval for at least one indication in the country of interest **DURYSTA® (bimatoprost intracameral implant); OZURDEX® (dexamethasone intravitreal implant); REFRESH® Portfolio of Artificial Tears; XEN® (gel stent)** * Real World Evidence (RWE)on effectiveness and safety of Durysta* * Impact of Early therapy adoption/switch to longer term outcomes* * Clinical outcomes in higher and lower risk patient groups (e.g.rapid vs slow progressors; thinner cornea, old age) * Sequential treatment approach with other IG interventions (e.g., laser,iDOSE,iStent, surgery) * Risk factors leading to corneal adverse and methods to decrease such events with Durysta(e.g., anatomic profile, placement, etc.) * Identification of predictors of long-term Intraocular Pressure (IOP)lowering effect with Durysta * Assess Durysta’s impact on adjunctive medication use beyond PGA drops * Assess cataract surgery combined with Durysta * Identify indicators for transition from drops/SLT to Durysta * Patient Selection and Clinical Outcomes including diverse patient population groups *Longer term data- 1-3 years **Refresh Artificial Tear Portfolio** * Quantification of the duration of relief of symptoms with Refresh artificial tears.

* Evaluate the effectiveness and safety of Refresh artificial tears in combination with other evidence-based dry eye therapies to identify optimal treatment algorithms * Real world outcomes and user experience of Refresh artificial tears (including preservative-free) in specific dry eye patient subtypes (i.e.meibomian gland dysfunction).

* Clinical outcomes in patients with dry eye symptoms associated with different lifestyle patterns(i.e.high screen time use, environmental exposures, or contact lens use) using Refresh artificial tears, focusing on improvements in quality of life, patient perception and objective symptom improvement.

* Improvement of patient outcomes with XEN via novel surgical techniques * Effectiveness and safety of XEN after failure of other MIGS procedures * Real world Data comparing with other bleb forming procedures (e.g.Trabeculectomy,other Bleb forming devices) or with Tube shunts * Trabeculectomy/other Bleb forming devices or repeat XEN after previously failed XEN surgery.

* Predictors of Rate of Progression (Slow vs Fast) in Glaucoma * Effectiveness and safety in Angle closure glaucoma * Effectiveness and safety in Normal Tension Glaucoma * Effectiveness and safety in diversified population/geographies *Wherever possible, long-term data 3+ years (VF progression, Endothelial cell count), 24 hr IOP control, desirable * Biomarkers in DME, and RVO:Identifying biomarkers of inflammation and relevance in disease process and response to treatment (with or without AI) * Biomarkers in DME, and RVO: Validating predictors of inflammation or Ozurdex therapeutic benefit (with or without AI).

* Benefit of targeting acute inflammation early in RVO with Ozurdex(prompt treatment) * Use of Ozurdex in phakic patients with DME * First and early switch to Ozurdex * Sequential use of Ozurdex and Anti-Vascular Endothelial Growth Factor (a-VEGF) (e.g.Ozurdex as 1st line). * Safety profile of Ozurdex in relationship to shorter or extended treatment intervals.

* Efficacy and safety of Ozurdex across indications (e.g.DME, RVO, Uveitis) in 1st line and early switch. * AI’s role in diagnosing, classifying, monitoring, and/or treating DME, RVO, and/or Uveitis. * Limitations of standards of care in DME * e.g.focusing on functional and anatomical outcomes switching between different a-VEGF agents.

* e.g.identifying patient sub-groups/clinical characteristics where limitations in aVEGF standard of care are more pronounced. * RWE in patients with suboptimal response to anti-VEGF therapy in DME/RVO. * Combination use of Ozurdex and anti VEGF.

* Impact of timely intervention in the development of ischemia in RVO Adalimumab (Humira), Risankizumab (Skyrizi), Upadacitinib (Rinvoq)** Pre-clinical and clinical proposals for diseases with high unmet need/burden, few to no suitable approved therapeutic options and strong rationale for target engagement in causality of disease may be submitted for consideration.

Real-world evidence assessing medication-taking behaviors, treatment patterns, disease and treatment outcomes in under-studied populations will be considered. Studies utilizing adalimumab will be considered only for investigating conditions with high disease burden and without suitable alternative treatment options, where sufficient evidence exists to support a hypothesis for life-altering outcomes.

**IMMUNOLOGY –GASTROENTEROLOGY Risankizumab (Skyrizi) & Upadacitinib (Rinvoq)** * Prevention and treatment of subsets of IBD, including but not limited to upper GI,pouchitis and ileal disease. * Broadening the knowledge on mechanisms contributing to IBD, predictive and prognostic factors to improve early and sustained control of inflammation in IBD to prevent disease worsening and optimize long term outcomes.

* Optimal monitoring of disease, including symptoms and inflammation in IBD, non-invasive mucosal healing monitoring tools (e.g., ultrasound, MRI), the evaluation of novel endpoints, and proposals of validation of monitoring tools, including but not limited to AI.

* Broadening and exploration of drug mechanisms, including but not limited to, JAK and IL-23, evaluation of biomarkers geared towards identifying different drivers of response, targeted therapy approaches, and developing and testing patient stratification hypotheses.

* Optimizing strategies to mitigate the holistic burden of IBD (total cost of illness, quality of life, co-morbidities, unmet needs) with special focus on underserved populations - such as those with limited access to healthcare resources, individuals facing socioeconomic, geographic, or cultural barriers, or groups experiencing disparities in health outcomes.

* Understanding of clinical treatment optimization strategies, including combination of treatments, and dosing, to optimize disease control with available therapies. **IMMUNOLOGY – DERMATOLOGY: Adalimumab (Humira), Risankizumab (Skyrizi), Upadacitinib (Rinvoq)** Indications: PsO, PsA, AD, HS, Vitiligo, AA** Priority consideration will be given to applications proposing to investigate the following areas of interest: 1.

Impact of treat-to-target strategies, treatment [](https://www. abbvie. com/science/clinical-trials/investigator-initiated-studies.

html)goals and initiatives to advance standards of care in managing disease, including research to understand the pathogenesis, disease course, and disease burden (including co-morbidities, CLCI) 2. Understanding treatment patterns, dosing, sequencing, compliance, persistence, adherence, and outcomes in diverse populations 3.

Burden of disease, including co-morbidities, predictors of disease progression, predictors of adverse drug reactions, psychosocial impact (stigma, mental health), access to care, and health care resource utilization (HCRU), as well as the cumulative long-term impact of disease across varying patient types (age, extent of disease, skin phototype) 4.

Biomarkers and other surrogate markers of prognosis or disease progression and predictors of response to different treatment modalities 5. Investigating the use of emerging and novel technologies for disease diagnosis, assessment, monitoring, and treatment management **Indication: Psoriatic Disease (PsO, PsA) Compound: Risankizumab (Skyrizi)** 1.

Evaluation of the impact of early intervention with Risankizumab in Psoriatic Disease and on the long-term disease burden, Evaluate the impact of Risankizumab in specific understudied sub-populations and on Psoriatic-associated comorbidities (i.e., reducing the risk for PsA, metabolic syndrome, cardiovascular and other co-morbidities) 2.

Real-world clinical evidence of Risankizumab in PsA in special populations common in Dermatology with oligoarthritis, early PsA, or high skin involvement with PsA. 3. Mechanistic studies investigating cytokine pathways and downstream effectors of IL23 pathway targeting therapies (example ligand vs cytokine signaling) **Indication: Atopic Dermatitis (AD) Compound: Upadacitinib (Rinvoq)** 1.

Effectiveness and/or safety of Upadacitinib in specific understudied sub-populations with AD 2. Understanding the importance and implementation of optimal treatment targets (e.g., minimal disease activity, EASI 90, itch NRS 0/1) and their value and impact to providers, patients and/or health systems. 3.

Impact of Upadacitinib on AD-related co-morbidities, associated conditions, inflammatory and/or pruritic dermatoses and lichenoid dermatoses 4. Optimization of UPA treatment for AD (i.e., dosing optimization, combination and/or sequence approaches) **Indication: Hidradenitis Suppurativa (HS)** 1.

Practical diagnostic, assessment, monitoring and imaging tools that aid in disease classification, assessment of disease severity, activity, progression, flares, response to treatment (including higher level efficacy) 2.

Patient types/segments, including the role of specific cytokine pathways (IL-1, JAK), as well as their needs with respect to disease management; biopsies & imaging modalities to assess the expression of IL1a and IL1b in samples 3.

Impact of early referral, diagnosis, and treatment in HS, including disease progression and consequences of underdiagnosis/undertreatment, and the epidemiology of HS to inform burden, patient segmentation, and optimization of clinical pathways. 4. Markers (clinical or biomarker) to predict rapid disease progression in HS patients, especially early-stage patients 5.

Optimization of treatment modalities for HS (i.e., dosing optimization, combination and/or sequence approaches) 1. Disease scoring and assessment measures, including QoL measures (e.g., patient impact) 2. Characterization and assessment of disease severity, disease activity, and disease progression 3.

Patient, HCP, Payer and Policy perspectives of the psychosocial burden of vitiligo and associated functional impact 4. Basic and clinical research to further characterize the natural course and/or history of disease, various endotypes, phenotypes of patients with vitiligo, and/or response to vitiligo treatments 5. Optimization of UPA treatment for vitiligo (i.e., dosing optimization, [](https://www.

abbvie. com/science/clinical-trials/investigator-initiated-studies.

html)combination and/or sequence approaches) **Indication: Alopecia Areata (AA)** * Disease scoring and assessment measures, including QoL measures, and quality of hair growth * Patient, HCP, Payer and Policy perspectives of the psychosocial burden of AA and associated functional impact * Basic and clinical research to further characterize the natural history of disease, various endotypes, phenotypes of patients with AA, and/or their response to AA treatments * Optimization of UPA treatment for AA (i.e., dosing optimization, combination approaches) **Other Immune-mediated Skin and Hair Diseases** 1.

Efficacy/effectiveness and safety of Risankizumab and Upadacitinib in other immune-mediated skin and hair diseases **IMMUNOLOGY – RHEUMATOLOGY: Rinvoq (Upadacitinib-UPA) and Skyrizi (Risankizumab-RISA)** **Rheumatology Overarching Priorities** * Use of JAKi and/or IL-23i in rheumatic inflammatory disease related to but not limited to adherence, persistence, treatment patterns/strategies and comparative effectiveness (observational or interventional) * Biomarkers predictive response to treatment and/or prognostic of disease progression * Outcomes associated with patients achieving and/or maintaining stringent disease control, including the development of novel endpoints that contribute significant new information to disease management * Addressing elements of standard of care, specifically, early and appropriate diagnosis, treatment targets, and understanding the role of Jak/IL-23 inhibition in implementing goal directed therapy * Effectiveness of switching to JAKi or IL-23i, versus cycling through the same previous MOA (e.g., in patients with lack of adequate response/intolerance to TNFi switching to a JAKi vs another TNFi/IL-17i) **Rheumatoid Arthritis (RA) Compound: Upadacitinib (Rinvoq)** * Refer to the Rheumatology Overarching Priorities **Giant Cell Arteritis (GCA) Compound: Upadacitinib (Rinvoq)** * Use of upadacitinib in GCA, related to but not limited to, effectiveness and treatment patterns/strategies in a clinical practice setting **System Lupus Erythematosus (SLE) Compound: Not Applicable** * Understanding the pathogenesis of SLE and the role of various inflammatory pathways (including JAK/STAT) in the development and propagation of both systemic and organ-specific disease including, but not limited to cutaneous, musculoskeletal, renal etc. * Characterization and impact of organ-specific tissue inflammation (e.g. synovitis, nephritis) with imaging/biopsy studies, including the potential of new outcome measures/endpoints * Identification of SLE endotypes, patients susceptible to flare, and gene signatures, soluble factors, or other biomarkers that can predict response to treatment and/or characterize patients who will not respond to current treatment modalities.

* Understanding the long-term disease burden including but not limited to quality of life, the real-world steroid burden- long-term impact on organ damage) including treatment patterns and adherence/persistence. **Spondyloarthritis (SpA) Overarching Priorities** * Identification of risk factors or biomarkers of progression from subclinical gut inflammation to clinical IBD (i.e. thresholds of fecal or serum calprotectin).

**Axial Spondyloarthritis (axSpA) Compound: Upadacitinib (Rinvoq)** * Real world impact of upadacitinib on core axSpA domains with a focus on stringent disease activity, pain, functioning and structural damage * Impact of upadacitinib on extra-musculoskeletal manifestations across the axSpA spectrum, including but not limited to, patients with concomitant IBD with clinical manifestations * Use of imaging modalities to assess the effectiveness of upadacitinib across the axSpA spectrum **Psoriatic Arthritis (PsA) Compound: Upadacitinib (Rinvoq)** * Real world impact of upadacitinib treatment on PsA domains (effectiveness including patient reported outcomes, safety and tolerability) * Impact of upadacitinib on extra-musculoskeletal manifestations in PsA, including but not limited to, patients with concomitant IBD with clinical manifestations * Evaluate the efficacy and safety of upadacitinib in specific understudied sub-populations and on psoriatic associated comorbidities (i.e., obesity, metabolic syndrome) including in combination with obesity therapies.

* Understanding novel treatment strategies involving upadacitinib, including but not limited to, treatment sequencing after an initial biologic **Psoriatic Arthritis (PsA) Compound: Risankizumab (Skyrizi)** * Impact of risankizumab treatment on PsA domains and related conditions (i.e., IBD and uveitis) with a focus on musculoskeletal symptoms, axial manifestations, and structural joint damage * Understanding novel treatment strategies involving risankizumab, including but not limited to, treatment sequencing after an initial biologic * Evaluate the efficacy and safety of risankizumab in specific understudied sub-populations and on psoriatic associated comorbidities (i.e., obesity, metabolic syndrome) including in combination with obesity therapies.

**NEUROSCIENCE – MIGRAINE: OnabotulinumtoxinA/BoNT/A (BOTOX®), ubrogepant (Ubrelvy), atogepant (Qulipta/Aquipta)** * Studies will only be considered for compounds that have received regulatory approval for at least one indication in the country of interest.

**Proposals for the topics listed below will NOT be considered:** * OnabotulinumtoxinA vs placebo, vs other toxins, vs mAbs(monoclonal antibodies) * Ubrogepant vs placebo, vs other acute treatments for migraine * Atogepant vs placebo, vs other preventive treatments for migraine * Double-blind, placebo controlled pediatric studies * Placebo controlled studies for treatment during premonitory/prodrome phase **Priority will be given to proposals investigating the following areas:** * Characterize and describe disease state across migraine * Impact of disease management on disease state including acute and preventive treatment patterns * Data describing the burden of menstrual migraine (defined as Pure Menstrual Migraine AND Menstrually-Related Migraine) including how patients treat or prevent these attacks * Impact of early intervention (e.g.first line of preventive treatment or early post-migraine onset) with migraine-specific treatment on migraine disease progression * Impact of triptan unsuitability on clinical and economic outcomes * Characterization of interictal burden and impact of treatment of interictal burden OnabotulinumtoxinA/BoNT/A (BOTOX®) - Chronic Migraine * OnabotA MOA in CM, including preclinical research to understand potential synergistic effect of onabotA used in combination with CGRP-targeted treatments (e.g.,atogepant) * Real-world effectiveness and safety of the combination treatment of onabotA and Atogepant, or CGRP Mabs in CM patients * Evidence on how onabotA treatment could improve patient outcomes for those CM patients who are not achieving optimal outcomes on CGRP mAbs * Safety and efficacy of onabotA use in patients with CM having concomitant conditions treated with additional injection paradigm (bruxism, CD, allodynia, peri-orbital pain) * Impact of onabotA on migraine associated co-morbidities, including the prevention of associated comorbidities (e.g. depression), functional outcomes, quality of life, health resource utilization and work productivity/return to daily activities and impact of non-headache symptoms (e.g. cognition, brain fog, fatigue,etc)Long-term (>2 yr) data to demonstrate sustained onabotA efficacy and safety * Real-world evidence demonstrating medico-economic impact of delaying treatment of patients with chronic migraine, including due to access limitations.

* Patient experience and satisfaction with onabotA treatment, including the benefits of regular HCP touchpoints * Data demonstrating patient’s benefit to expand injection procedure to non-neurologist i.e., pain specialists, nurses, clinical specialists (efficacy/safety/persistence/satisfaction) Ubrogepant (Ubrelvy) - Acute Treatment of Migraine * Evaluation of effectiveness of ubrogepant in combination with other migraine treatments * Data demonstrating the effectiveness of ubrogepant across all phases of migraine * Impact of ubrogepant use and Medication Overuse Headache (MOH) * Ubrogepant efficacy and safety in new/different indications Atogepant (Qulipta®/Aquipta®) – Preventive Treatment of Migraine * Evaluation of effectiveness of atogepant with other migraine treatments (acute or preventive) * Characterize atogepant’s MOA as it pertains to weight changes in people with migraine with pre-clinical and clinical evidence * Evidence for how economic, social, and societal outcomes can improve after early intervention (e.g.first line of preventive treatment or early post-migraine onset) with atogepant in their treatment journey * Impact on ictal/interictal QoL and non-HA symptoms (including function, daily activities, etc.), and work productivity and/or cognition * Evaluation of effectiveness of atogepant in people with migraine 60 years of age or older **NEUROSCIENCE – NEUROTOXIN THERAPEUTICS: Botox (OnabotulinumtoxinA/BoNTA)** The purpose of this document is to describe the IIS Strategic Priorities for Botox indications, neurotoxin science and novel evidence generation in movement disorders: * Toxin Science and Novel Indications For Migraine and for Botox Cosmetics indications, please refer to the applicable sections * Limited funds may be available to support proposals **Proposals for the topics listed below will NOT be considered:** * Studies conflicting with current research and development programs and strategies * For Spasticity – Assessment of anticoagulants pre/post injection procedure * For Urology – Evaluation of Botox for Premature Ejaculation (PE) or Benign Prostatic Hypertrophy (BPH) * For Tremor – Evaluation of Botox in Essential Tremor * Studies for pain indications not otherwise specified below **Priority will be given to proposals investigating the following areas:****Toxin Science and Novel Indications** * Real world evidence of clinical and health economic outcomes of Botox utilization versus other toxins, including the consequences of toxin switching * Botox utilization in multi-indication patients * Novel indications, applications and treatment paradigms in alignment with areas of company focus * Pain, sensory, anti-inflammatory mechanisms of action of Botox * Non-classical mechanism of action of Botox * Preclinical studies assessing Botox versus other toxins * Studies evaluating screening tools and biomarkers for early identification and/or efficacy and/or predictors for early spasticity diagnosis and treatment * Optimization of Botox therapy through the integration of other therapies, new technologies, and training tools * Studies that assess Health Equity and Social Determinants of Health in Spasticity Management * Clinical and/or Pharmacoeconomic impact of early diagnosis and intervention * Studies assessing approaches/predictors for prompt diagnosis and early intervention with Botox for Cervical Dystonia to obtain optimized patient outcomes * Optimization of Botox therapy with utilization of new technologies and training tools * Impact of treatment adherence/discontinuation on pharmacoeconomic and/or patient outcomes * Studies that assess Health Equity and Social Determinants of Health in Cervical Dystonia * Studies to assess long-term real-world economics, safety and/or effectiveness of Botox in OAB and/or NDO * Studies to assess Botox use for overactive bladder conditions or other urological/urogynecologic conditions in males and females * Assessment of procedure setting or utilization of tailored treatment approach including comfort techniques during the procedure relating to treatment adherence and/or patient satisfaction * Studies to assess variables that impact time between diagnosis and advancement to minimally invasive therapies * Studies that assess Health Equity and Social Determinants of Health in Urology * Studies that assess diagnosis and disease classification in essential tremor * Studies focusing on the unmet patient needs related to treatment goals and care gaps in essential tremor **NEUROSCIENCE –PARKINSON’S DISEASE: VYALEV of PRODUODOPA, [Foslevodopa/Foscarbidopa (LDp/CDp)]** * Studies will only be considered for compounds that are on market and available in the country of interest.

**Proposals for the topics listed below will NOT be considered:** * Head-to-head proposals between device aided therapies **Priority will be given to proposals investigating the following areas:** * Disease burden/Progression: * Evidence to demonstrate that uncontrolled symptoms in patients on oral therapies impose a significant 24-hour burden, affecting activities of daily living, sleep quality, psychosocial well-being, and work productivity.

* Examples include—but are not limited to—sleep disturbances, daytime sleepiness, impaired daytime functioning, fatigue, depression, pain, and GI dysfunction. Additionally, the impact may be more pronounced in underserved populations.

\ * Data to characterize the long-term negative consequences of pulsatile oral therapies (e.g., IR/ER LD/CD) and cycling through adjunctive oral therapies (e.g., D2/3 DAs, MAOBs, etc) on PD symptom progression (including risks of treatment related adverse events) and patients’ mental and physical functioning (i.e., impacts on ADLs and QoL).

* Clinical utility of diagnostics or technology (including AI and digital health technologies) to identify signs and symptoms of Advancing Parkinson’s Disease and resultant changes in care.

* Understand the right time for intervention (and provide referral, if needed) using different tools (i.e., Tools/Criteria such as “5-2-1”, My PD-Care, and MANAGE-PD; biomarkers, technology based objective measures (TOM) for use by HCP, patient/caregiver, and patient foundations/associations.)

* Evidence related to integrated care models where healthcare professionals (i.e., GNs, MDS’s Networks) work in tandem ensuring aPD patients receive optimal and timely treatment. * Evaluate patient motivations or barriers to refusal or initiation of invasive treatment (with a focus on subcutaneous infusion options) despite insufficient symptom control.

**Continuous dopaminergic stimulation (CDS) with or without Foslevodopa/Foscarbidopa (LDp/CDp)** * Short and long-term assessment (including but not limited to laboratory, clinical, imaging) of CDS vs pulsatile stimulation (oral medication), including but not limited to use in earlier stages of PD to assess the ability of continuous therapies for disease modification and prevention/delay of motor complications.

* Assessment of CDS therapies to partially or completely reverse synaptic plasticity / widen the therapeutic window (including but not limited to laboratory, clinical, imaging) * Pharmacological effects of CDS over 24 hrs.

* Investigate indicators/markers (including but not limited to laboratory, clinical, imaging) to provide evidence to support whether continuous drug delivery translates to continuous dopaminergic stimulation in patients. * Evaluate preclinical impact of CDS on neuroinflammation.

**Foslevodopa/Foscarbidopa (LDp/CDp)** _**Patient Selection or Characteristics**_ * Evaluate LDp/CDp efficacy and safety in subpopulations of advanced PD (APD) patients uncontrolled on orals including, but not limited to: age <65 years, Body-Mass-Index subgroups (e.g. BMI <18. 5, 18. 5-25, >25), cognitively impaired, patients with impulse control disorders (ICDs), and underserved populations such as diverse ethnicities/race/gender.

* Evaluate device-aided therapy sequencing patterns (including but not limited to LDp/CDp to LCIG or vice versa, or LDp/CDp to other device-aided therapies and vice versa).

* Evaluate efficacy and safety in PD patients earlier within “advanced” PD (e.g., time to motor fluctuations < 3 years, less daily motor complication burden (eg OFF time 2 - 4 hours), shorter disease duration), “active” patients (e.g., with regards to exercise levels and work ability).

**_Efficacy and Safety Measures_** * Further understand the efficacy and safety (including responder analyses/characteristics), including but not limited to: * Motor efficacy including but not limited to dyskinesia, freezing of gait, and axial symptoms.

* Patient and caregiver-related outcomes, preferences, and satisfaction (patient/caregiver experience), activities of daily living (ADL), quality of life (QoL), perceived independence/self-efficacy, caregiver burden. * General or specific Non-Motor Symptoms (NMS) including but not limited to sleep, apathy, fatigue, pain, gastrointestinal dysfunction, sexual dysfunction, nocturia, orthostatic hypotension, cognition, mood.

* Morning akinesia/early-morning OFF or early-morning dystonia * Using Technology based Objective Measurements (e.g., wearable devices, biosensors, and others) as surrogates of efficacy and safety of LDp/CDp in APD patients, including but not limited to (nighttime) mobility, sleep.

* Utilization of Artificial Intelligence in validated models to broadly characterize LDp/CDp real world effectiveness (i.e., patient selection, outcomes, switch patterns, discontinuation) * Health care resource utilization, caregiver burden, work productivity, cost-effectiveness, societal impact (e.g., return to activity, outreach/life space, social participation, lifestyle), stigma, delay in nursing home admission.

* Long-term data on effectiveness and safety, including infusion site events, predictors, root cause evaluation (i.e., inflammatory process), factors leading to discontinuations and interventions to improve adherence / development and evaluation of protocols for the structured routine support of patients on treatment. **_Initiation/Titration/Practical Outcomes_** * Understand treatment initiation titration and the impact of