A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata

NCT06873945
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,330
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Lead sponsor
Pfizer
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Start date
2025-04-01
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Number of sites
147
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Summary
The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose. This study is seeking participants who: * Are 12 years of age or older (Part 1) * Are 12 to less than 18 years (Part 2) * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in Part 1 of this study. About 80 participants will take part in Part 2 of this study. In Part 1, participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. In Part 2, all eligible participants will receive ritlecitinib 100 mg taken by mouth once daily. The data from this part of the study will be combined with the data from Part 1 of the study to help to see if the 100 mg dose of ritlecitinib is safe and effective in adolescent patients with alopecia areata. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes (Part 1 only). Participants will also be asked to complete questionnaires about their alopecia areata.
clinicaltrials.gov
Acronym
ALLEGRO-100
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Short title
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
clinicaltrials.gov
Official title
A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA
clinicaltrials.gov

Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-03-19
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First posted
2025-03-13
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Registry last updated
2026-08-13
clinicaltrials.gov
Primary completion date
2028-03-19
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Start date
2025-04-01
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Participants
1,330
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
1,330
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Protocol amendments
2
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Number of sites
147
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06873945
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06873945
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Part 1 of the study will be blinded. Part 2 of the study will not be blinded.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Part 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20

    Timeframe: Week 24

    Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg once-daily (QD) versus placebo

  2. Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation

    Timeframe: Baseline to Follow-up visit (Week 52)

    Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD

  3. Part 2: Percentage of participants with clinically significant laboratory abnormalities

    Timeframe: Baseline to Follow-up visit (Week 52)

    Percentage of participants with clinically significant laboratory abnormalities, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD

  1. Part 1: Percentage of participants with absolute SALT score less than or equal to 20

    Timeframe: Week 24

    Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg QD versus placebo

  2. Part 1: EU Only: Percentage of participants with Patient Global Impression of Change (PGI-C) response, defined as a score of "moderately improved" or "greatly improved"

    Timeframe: Week 24

    Difference in percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

  3. Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20

    Timeframe: Week 36

    Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus placebo

  4. Part 1: Change from baseline in SALT score

    Timeframe: Week 24

    Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  5. Part 1: Percentage of participants with absolute SALT score equal to 0

    Timeframe: Week 24

    Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

  6. Part 1: Percentage of participants with absolute SALT score less than or equal to 10

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  7. Part 1: Percentage of participants with absolute SALT score less than or equal to 20

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  8. Part 1: Percentage of participants with absolute SALT score equal to 0

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with SALT score equal to 0 between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  9. Part 1: Change from baseline in SALT score

    Timeframe: Baseline through Week 24

    Difference in the mean absolute change from baseline in SALT score between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  10. Part 1: Percentage of participants with EBA (Eyebrow Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  11. Part 1: Percentage of participants with ELA (Eyelash Assessment) response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  12. Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"

    Timeframe: Baseline through Week 24

    Difference in the percentage of participants with PGI-C response between ritlecitinib 100 mg QD versus ritlecitinib 50 mg QD

  13. Part 1: Percentage of participants with absolute SALT score less than or equal to 10

    Timeframe: Week 24

    Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

  14. Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)

    Timeframe: Week 24

    Difference in the percentage of participants with EBA response (among participants without a normal EBA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

  15. Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)

    Timeframe: Week 24

    Difference in the percentage of participants with ELA response (among participants without a normal ELA score at baseline) between ritlecitinib 100 mg QD versus placebo and ritlecitinib 50 mg QD versus placebo

  16. Part 1: Percentage of participants with absolute SALT score less than or equal to 20

    Timeframe: Week 48

    Difference in the percentage of participants with SALT score less than or equal to 20 between ritlecitinib 50 mg non-responder (NR)--\>ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR--\>ritlecitinib 50 mg QD

  17. Part 1: Percentage of participants with absolute SALT score less than or equal to 10

    Timeframe: Week 48

    Difference in the percentage of participants with SALT score less than or equal to 10 between ritlecitinib 50 mg NR--\>ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR--\>ritlecitinib 50 mg QD

  18. Part 1: Change from Week 24 in SALT score

    Timeframe: Week 48

    Difference in the mean absolute change from Week 24 in SALT score between ritlecitinib 50 mg NR--\>ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR--\>ritlecitinib 50 mg QD

  19. Part 1: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"

    Timeframe: Week 48

    Percentage of participants with PGI-C response between ritlecitinib 50 mg NR--\>ritlecitinib 100 mg QD versus ritlecitinib 50 mg NR--\>ritlecitinib 50 mg QD

  20. Part 1: Percentage of participants with absolute SALT score less than or equal to 20

    Timeframe: Week 24 through Week 48

    Percentage of participants with SALT score less than or equal to 20 for ritlecitinib 100 mg QD, ritlecitinib 50 mg responder (R)--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

  21. Part 1: Percentage of participants with absolute SALT score less than or equal to 10

    Timeframe: Week 24 through Week 48

    Percentage of participants with SALT score less than or equal to 10 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

  22. Part 1: Percentage of participants with absolute SALT score equal to 0

    Timeframe: Week 24 through Week 48

    Percentage of participants with SALT score equal to 0 for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

  23. Part 1: Change from Week 24 in SALT score

    Timeframe: Week 24 through Week 48

    Mean absolute change from Week 24 in SALT score for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

  24. Part 1: Percentage of participants with EBA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal EBA score at baseline)

    Timeframe: Week 24 through Week 48

    Percentage of participants with EBA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

  25. Part 1: Percentage of participants with ELA response, defined as at least a 2-grade improvement from baseline or a score of 3 (among participants without a normal ELA score at baseline)

    Timeframe: Week 24 through Week 48

    Percentage of participants with ELA response for ritlecitinib 100 mg QD, ritlecitinib 50 mg R--\>50 mg QD, ritlecitinib 50 mg NR--\>50 mg QD, and ritlecitinib 50 mg NR--\>100 mg QD

And 10 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults, Older adults
Minimum age
12 Years
Healthy volunteers
No

Age:

  1. 18 years of age or older 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. In Part 2 of the study, only adolescents (12 to <18 years of age at both Screening and Day 1) who did not participate in Part 1 will be enrolled.

    Disease Characteristics:

  2. Must meet the following alopecia areata criteria at both Screening and Baseline:

    1. Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
    2. ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
    3. Current episode of hair loss ≤10 years.

Medical Conditions:

  1. Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause hair loss.

  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.

  3. Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.

  4. General Infection History:

    • Have 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. NOTE: participants may be rescreened after the infection resolves.
    • Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.

  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.
    • Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.

  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.
    • 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.

  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.

  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.

    Prior/Concomitant Therapy:

  9. Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines.

    Prior/Concurrent Clinical Study Experience:

  10. Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this study. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib.

    Diagnostic Assessments:

  11. Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.

  12. Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities.

    Other Exclusion Criteria:

  13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Sources for eligibility
clinicaltrials.gov

  • The Kirklin Clinic of UAB Hospital (Radiology)Birmingham, United StatesActive, not recruiting
  • University of Alabama at Birmingham Faculty Office Towers (Regulatory)Birmingham, United StatesActive, not recruiting
  • University of Alabama at BirminghamBirmingham, United StatesActive, not recruiting
  • Burke Pharmaceutical ResearchHot Springs, United StatesActive, not recruiting
  • Doc1 Healthcare SystemsBrea, United StatesRecruiting
  • California Dermatology & Clinical Research InstituteEncinitas, United StatesActive, not recruiting
  • Marvel Clinical ResearchHuntington Beach, United StatesActive, not recruiting
  • University of California - IrvineIrvine, United StatesRecruiting
  • Gavin Herbert Eye InstituteIrvine, United StatesRecruiting
  • Southern California Clinical ResearchSanta Ana, United StatesActive, not recruiting
  • Brett King MD, LLCFairfield, United StatesActive, not recruiting
  • Alliance for Multispecialty Research, LLCFort Myers, United StatesActive, not recruiting
  • Robert B. Pritt, DO, PAFort Myers, United StatesActive, not recruiting
  • Pediatric Skin ResearchMiami, United StatesActive, not recruiting
  • Skin Research of South FloridaMiami, United StatesActive, not recruiting
  • ForCare Clinical ResearchTampa, United StatesActive, not recruiting
  • Olympian Clinical Research - Tampa - Memorial HighwayTampa, United StatesActive, not recruiting
  • Endeavor Health Audiology -CHICAGOChicago, United StatesActive, not recruiting
  • Endeavor Health Audiology -LAKE BLUFFLake Bluff, United StatesActive, not recruiting
  • Endeavor Health Audiology-NORTHBROOKNorthbrook, United StatesActive, not recruiting
  • Endeavor Health Audiology-SKOKIESkokie, United StatesActive, not recruiting
  • Endeavor Health Imaging & Radiology Serviccs - Old OrchardSkokie, United StatesActive, not recruiting
  • Endeavor Health Lab Services - Old OrchardSkokie, United StatesActive, not recruiting
  • Endeavor HealthSkokie, United StatesActive, not recruiting
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesActive, not recruiting

And 122 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-519370-40-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (6)