Investigating the Benefit of Early Treatment with Ritlecitinib in Alopecia Areata: A Real-World Evidence Approach

Investigating the Benefit of Early Treatment with Ritlecitinib in Alopecia Areata: A Real-World Evidence Approach is sponsored by Pfizer. This research grant seeks proposals to investigate the benefits of early treatment with Ritlecitinib in Alopecia Areata through real-world evidence in the USA.

Pfizer Research Grant Request for Proposals Competitive Grant Program – Pfizer Internal Review Process # Investigating the Benefit of Early Treatment with # Ritlecitinib in Alopecia Areata: A Real-World Evidence Approach Alopecia Areata (AA) is a chronic, immune-mediated condition causing non-scarring hair loss that affects about 2% of the global population and can lead to substantial psychosocial burden if disease is severe and untreated.

The treatment landscape has recently evolved with the approval of ritlecitinib, a systemic therapy for severe AA in adults and adolescents aged 12 years and older, based on efficacy demonstrated in the ALLEGRO phase 2b/3 program. Despite this advance, important questions remain regarding the optimal timing of therapy initiation.

Emerging post-hoc analyses from the ALLEGRO program indicate that patients with shorter disease duration and lower baseline severity achieve higher response rates, suggesting that earlier intervention with ritlecitinib may lead to improved outcomes.

Project Types and Area of Interest This RFP seeks research that uses real-world evidence to evaluate the impact of early versus delayed initiation of ritlecitinib in alopecia areata, including clinical outcomes, disease trajectory, and comparisons with conventional treatment pathways. Proposals should also explore patient and disease characteristics that predict benefit from early intervention.

Please refer to page 2 for the full Area of Interest and detailed scope of this RFP. Funding Range and Project Length Individual projects requesting up to $100,000 USD will be considered. Maximum project length is 24 months.

Submission Deadline Anticipated Grant Award Notification Anticipated Project Start Date 17 September 2026 November 2026 14 July 2026 2 Applicant Eligibility Criteria: The institution and Principal Investigator (PI) must be based in one of the eligible countries noted above.

Only organizations are eligible to receive grants, not individuals or medical practice groups (i.e., an independent group of physicians not affiliated with a hospital, academic institution, or professional society).

If the project involves multiple departments within an institution and/or between different institutions / organizations / associations, all institutions must have a relevant role and the requesting organization must have a key role in the project. The PI must have a medical or postdoctoral degree (MD, PhD, or equivalent), an advanced nursing degree (BSN with a MS/PhD), or a degree in Pharmacy, Physiotherapy, or Social Work.

The applicant must be the PI or an authorized designee of such individual (e.g., PI’s research coordinator). The PI must be an employee or contractor of the requesting organization. Requesting organization must be legally able to receive award funding directly from Pfizer Inc. We strongly recommend that applicants confirm this with their organization or institution prior to submitting an application.

Grants awarded to organizations that are subsequently found to be unable to accept funding directly from: Pfizer Inc. may be subject to rescission.

Primary Area of Interest: General Area of Interest for this RFP: Research proposals that will be considered for Pfizer support will focus on the following: Real-world data on the impact of early vs. delayed initiation of ritlecitinib on clinical outcomes in AA , including hair regrowth (SALT response), time to response, durability of response, and relapse rates.

Understanding of baseline patient characteristics and disease features that predict benefit from early ritlecitinib treatment , including but not limited to: disease and episode duration, baseline SALT score, extent of hair loss (AT/AU vs. non-AT/AU), age, prior treatment history, and biomarkers of disease activity.

Comparative real-world evidence evaluating outcomes of patients treated with ritlecitinib early in their disease course vs. those who received conventional therapies first before transitioning to ritlecitinib.

Disease Trajectory and potential for disease modification with early ritlecitinib intervention ,including the impact on relapse frequency, flare severity, treatment sustainability, long-term disease trajectory in diverse patient populations, as well as impact on comorbidities.

Please note that this Request for Proposals (RFP) does not accept requests for the provision, purchase, development, formulation, or supply of drug compounds (including investigational or approved products). Proposals that include requests for drug compounds will be considered out of scope and will not be reviewed.

3 Expected Approximate Monetary Range of Grant Applications: IMPORTANT: Grants will be distributed following a fully executed agreement and submission of Final Protocol, Documentation of IRB/IEC Approval, Regulatory Approval (if applicable), Exemption or Waiver.

Organizations must obtain approval from an Institutional Review Board (IRB) for their proposal to be eligible to receive the grant award if IRB approval is required for study execution. It is not mandatory to have IRB approval at the time of proposal submission.

However, organizations are anticipated to secure an IRB evaluation subsequent to the award notification and must ensure that the approval is in place prior to 1 st Individual projects requesting up to $100,000 USD will be considered. The estimated total available budget related to this RFP is $200,000 USD. Award amounts include direct costs, institutional overhead costs (capped at 28% per Pfizer policy), and indirect costs.

IMPORTANT: Be advised applications submitted after the due date will not be reviewed. *Please note the deadline is 23:59 Eastern Standard Time (e.g., New York, GMT -5) IMPORTANT: Please read this section carefully since applications submitted not following these instructions will not be accepted and will be cancelled. Note: there are individual portals for each grant application type.

Please be sure to use the URL above. First-time users should click “Create your password”. Click the “Start A New Research Grant Application” button.

Requirements for submission: Complete all required sections of the online application IMPORTANT: Upload proposal (see Appendix) in the Proposal/Protocol field. For the question “ Competitive Grant?

” select “ Yes ” Select the following Primary Area of Interest: Dermatology - Alopecia Areata - RES Select the following Competitive Grant Program Name: 2026 I&I US AA Early Treatment RES If you encounter any technical difficulties with the website, please click here or the “Technical Questions” link at the bottom of the page in Cybergrants. Please click here to view “Frequently Asked Questions” regarding the Competitive Grant Program.

If you have questions regarding this RFP, please direct them in writing to the Grant Officer, Talita Honorato-Rzeszewicz (talita. honorato-rzeszewicz@pfizer. com ), with the subject line “2026 I&I US AA Early Review and Approval Process: Grant requests received in response to a general RFP are reviewed by Pfizer to make final grant decisions.

Mechanism by which Applicants will be Notified: All applicants will be notified via email by the dates noted above. Applicants may be asked for additional clarification during the review period. If your grant is approved, your institution will be required to enter into a written grant agreement with Pfizer.

Please click here to view the core terms of the agreement. Under Pfizer's competitive grant program, modifications to grant agreements will not be reviewed unless a genuine conflict exists as between applicable law and the terms of the relevant grant agreement. Applicant is encouraged to share the core terms with counsel for approval prior to submitting an application.

Except where prohibited by applicable law and, in any case, subject to review by Pfizer Legal, payment of grant funding may only be paid to the grantee organization. This RFP is supported by Pfizer Inc. and, if approved, payment will be sent from the United States.

Pfizer supports the global healthcare community’s independent initiatives (e.g., research, quality improvement or education) to improve patient outcomes in areas of unmet medical need that are aligned with Pfizer’s medical and/or scientific strategies.

Pfizer’s competitive grant program involves a publicly posted general Request for Proposal (RFP) that provides detail regarding a general area of interest, sets timelines for review and approval, and uses an internal Pfizer review process to make final grant decisions. Organizations are invited to submit an application addressing the research gaps as outlined in the specific RFP.

For all Investigator Sponsored Research (ISRs) and general research grants, the grant requester (and ultimately the grantee) is responsible for the design, implementation, sponsorship, and conduct of the independent initiative supported by the grant, including compliance with any regulatory requirements.

Pfizer must not be involved in any aspect of study protocol or project development, nor the conduct or monitoring of the research program. An ISR grant request cannot be submitted for a study that has already commenced and was not originally supported by Pfizer. 5 IMPORTANT: RFP Submission Requirements Applications will be accepted via the online portal listed in the How to Submit section.

Project Proposals/Protocols should be single-spaced using Calibri 12-point font and 1-inch margins. Note there is a 15-page limit exclusive of references. When uploading your Full Proposal please ensure it addresses the following sections: Provide the main goal of the study and the study population (if applicable).

Provide a detailed definition that is directly linked to the primary objective. Assessment of Need for the Project This should reflect your study rationale. Provide a brief description of the medical/scientific question and the rationale of how this trial or study addresses the question.

Describe the primary audience(s) targeted for this project. For Investigator Sponsored Clinical Trials, please specify the age, gender and other demographic information for trial population. Also indicate whom you believe will directly benefit from the project outcomes.

Describe the overall population size as well as the size of your sample population. Project Design and Methods Describe concisely the research design and methods for achieving the stated goals. For a clinical interventional study, include inclusion/exclusion criteria, treatment plan and statistical plan.

Explain what measures you have taken to assure that this project idea is original and does not duplicate other projects. Describe how this project builds upon existing work, pilot projects, or ongoing projects developed either by your institution or other institutions related to this project. Specify type and frequency of safety, efficacy, and/or outcome measures.

Also indicate the method(s) used to assess measures. Provide a publication plan describing intended submission of abstracts to (a) congress(es) or intended submission of (a) publication(s) to peer-reviewed journals. Anticipated Project Timeline Provide an anticipated timeline for your project including project start/end dates.

An ISR grant request cannot be submitted for a study that has already commenced and was not originally supported by Pfizer. If there is any additional information you feel Pfizer should be aware of concerning the importance of this project, please summarize here. Early-career applicants: Letter(s) of support from mentor(s) and collaborators describing how the award will advance the applicant’s career.

This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used [laboratory, animal, clinical and “other”]. If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project.

The budget amount requested must be in U.S. dollars (USD). 6 While estimating your budget please keep the following items in mind: General organizational running costs such as legal fees, insurance, heating, and lighting etc. should be included in an Institutional Overhead (if required). These costs are not specific to a grant request and therefore, should not appear as line items in budgets.

However, costs that are specific to the study (e.g., some countries require insurance to be taken out on a per-study basis for clinical research) would be acceptable to be included as line items. The inclusion of these costs cannot cause the amount requested to exceed the budget limit set forth in the RFP.

Pfizer does not provide funding for capital purchases (infrastructure expenses such as equipment, purchases of software or software licenses, technology or bricks and mortar). Equipment hire/leasing is acceptable and may be included in project budget. It should be noted that grants awarded through GMGP cannot be used to purchase Pfizer therapeutic agents (prescription or non-prescription).

Pfizer maintains a company-wide, maximum allowed overhead rate of 28% for independent studies and projects. Please click here for details. IRB approval if applicable Organizations must obtain approval from an Institutional Review Board (IRB) for their proposal to be eligible to receive the grant award if IRB approval is required for study execution.

It is not mandatory to have IRB approval at the time of proposal submission. However, organizations are anticipated to secure an IRB evaluation subsequent to the award notification and must ensure that the approval is in place prior to 1 st