RITLECITINIB TOSILATE for Alopecia areata

Inclusion criteria

• {"criterion_text":"- 1. 18 years or older (or the minimum age of consent in accordance with local regulations) at screening. Adolescents (12 to <18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if applicable). Where these approvals have not been granted, only participants 18 years of age and older at screening will be enrolled.\n- 2. Must meet the following AA criteria at both Screening and Baseline: a. Have a clinical diagnosis of AA with no other etiology of hair loss. b. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months. •Photographs taken at Screening must be submitted to the Sponsor’s designee for verification of SALT score ≥50 and hair loss due to AA. Participants must not be randomized until verification has been confirmed. c.\tCurrent episode of hair loss ≤10 years."}

Exclusion criteria

• {"criterion_text":"- 1. Diseases or conditions affecting hair loss\n- 2. History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.\n- 3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria: •Suicidal ideation associated with actual intent and a method or plan in the past year: “Yes” answers on items 4 or 5 of the C-SSRS administered at the Screening visit (see Section 8.3.10). •Previous history of suicidal behaviors in the past 5 years: “Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS. •For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior.\n- 4. General Infection History: •Having a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the investigator, within 3 months prior to Day 1.•Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1. •Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB.\n- 5. Specific Viral Infection History: • History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster. •\tInfected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility. •\tHave a known immunodeficiency disorder (including positive serology for HIV at Screening) or a first-degree relative with a hereditary immunodeficiency (unless known negative carrier status).\n- 6. Other Medical Conditions: •Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere’s disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating or progressive. •Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy. Chest imaging may be performed up to 12 weeks prior to Screening. Documentation of the official reading must be located and available in the source documentation. •Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. •Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease. •Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. Participants with elective surgery scheduled to occur during the study can only be enrolled with approval of the sponsor.\n- 7. Adolescent participants 12 to <18 years of age without one of the following: •Documented evidence from a health professional of having received varicella vaccination (2 doses); or •Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening. Note: Serological testing must be performed for VZV immunoglobulin G (IgG) antibody (Ab) only in the absence of documented evidence from a health professional of having received varicella vaccination (2 doses). If serological testing is performed in the presence of documented evidence of having received varicella vaccination (2 doses), participants are eligible to enter the study regardless of the result of serological testing.\n- 8. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study."}

Primary endpoints

• {"endpoint_text":"- SALT ≤20 response at Week 24","definition_or_measurement_approach":"SALT score measured at Week 24; primary endpoint is achievement of SALT score ≤20 at Week 24 (i.e., response defined as SALT ≤20 at Week 24)."}

Secondary endpoints

• {"endpoint_text":"- SALT ≤20 response at Week 24","definition_or_measurement_approach":"SALT score measured at Week 24; endpoint defined as SALT ≤20 at Week 24."}
• {"endpoint_text":"- PGI-C response, defined as a score of “moderately improved” or “greatly improved” at Week 24","definition_or_measurement_approach":"Patient Global Impression of Change (PGI-C) assessed at Week 24; responder defined as score of “moderately improved” or “greatly improved.”"}
• {"endpoint_text":"- CFB in SALT score at Week 24","definition_or_measurement_approach":"Change from baseline (CFB) in SALT score measured at Week 24 compared to baseline."}

Methods

• Site-based recruitment materials: posters, flyers, leaflets, patient brochures targeted to adults (18+) and adolescents (12-17) (documents K3/K2/K12/K11 and site-specific flyers/posters) — country-specific materials for Poland, Czechia, Spain (document filenames indicate country/site versions).
• Database letters / confirmation emails to potential participants (documents K10, K6) — targeted by age group (12-17 and 18+ indicated).
• Prescreener tools and call scripts for telephone screening (document K15, K5) — site use to pre-screen respondents.
• Social media posts and digital adverts: Facebook Page posts and screenshots (K8, K7), Instagram posts and reels (K22, K24) — Poland site materials referenced.
• Website entries / site web postings and study fact sheets for public-facing recruitment (K21, K19, K18, K17) — targeted to adults and adolescents as per material naming.
• Patient video with QR code for distribution (K13) and other QR code materials to link to digital content.
• Country-specific recruitment arrangements documents (K1a/K1) providing the overall recruitment plan per country (Poland, Czechia, Spain).

Spain

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

28

Number Of Sites

5

Number Of Participants

2

Poland

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

35

Number Of Sites

14

Number Of Participants

55

Czechia

Earliest CTIS Part Ii Submission Date

12-05-2025

Latest Decision Or Authorization Date

21-07-2025

Processing Time Days

70

Number Of Sites

3

Number Of Participants

17

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Sponsor duties code 4

Name

Premier Research

Responsibilities

Dictionary Coding, User Acceptance Testing

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Premier Research","duties_or_roles":"Dictionary Coding, User Acceptance Testing","organisation_type":"Industry"}
• {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photo documentation","organisation_type":"Pharmaceutical company"}