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RecruitingNCT06873945ALLEGRO-100Updated Oct 20, 2026

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

A Phase 3 interventional study of Ritlecitinib 100 mg and Ritlecitinib 50 mg in Alopecia Areata, sponsored by Pfizer. Recruiting at 148 sites in 11 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Updated Oct 20, 2026Site recruiting status changed3 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
674
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Alopecia Areata

Keywords

  • alopecia universalis
  • alopecia totalis
  • alopecia
  • patchy hair loss
  • diffuse hair loss
  • ophiasis
  • hair disease
  • Ritlecitinib
  • Litfulo
  • hair loss
  • adolescents
  • adults
03

In context

Alopecia Areata

220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.

This study's planned enrollment of 674 is above the median of 50 across 171 interventional studies indexed under Alopecia Areata.

Browse Alopecia Areata studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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/ to any component (including ) 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 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 or 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 . 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 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 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
674 participants (estimated)

Study arms

  • Experimental
    Ritlecitinib 50 mg

    Participants in Part 1 will be randomized to Ritlecitinib 50 mg QD for 24 weeks. Depending on response status at Week 24 (ie, whether the participant has a SALT score of less than or equal to 20), the participant may be re-randomized to Ritlecitinib 50 mg QD or Ritlecitinib 100 mg QD for another 24 weeks. Data from participants who are non-responders (ie, had a SALT score greater than 20) at Week 24 and re-randomized to Ritlecitinib 50 mg will be augmented with data from an External Ritlecitinib 50 mg QD Group for comparisons at Week 48. The External Ritlecitinib 50 mg QD Group will be constructed using patient-level data from the appropriately chosen Pfizer clinical study in participants who received Ritlecitinib 50 mg QD and were non-responders at Week 24 and continued receiving ritlecitinib 50 mg QD up to Week 48. In addition to the active Ritlecitinib 50 mg capsule, a placebo capsule matching the Ritlecitinib 100 mg capsule will be given in order to maintain the blind.

    Drug: Ritlecitinib 50 mg · Drug: Placebo - 100 mg

  • No intervention
    External Placebo

    This group will be constructed using participant-level data at Week 24 from placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata. This data will be used for comparison between each Ritlecitinib dose and placebo at Week 24. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.

  • Experimental
    Ritlecitinib 100 mg (open-label)

    Participants in Part 2 will be assigned to receive one open-label Ritlecitinib 100 mg capsule once daily by mouth for 48 weeks.

    Drug: Ritlecitinib 100 mg

  • Experimental
    Ritlecitinib 100 mg

    Participants in Part 1 will be randomized to Ritlecitinib 100 mg QD for 48 weeks. In addition to the active Ritlecitinib 100 mg capsule, a placebo capsule matching the Ritlecitinib 50 mg capsule will be given in order to maintain the blind.

    Drug: Ritlecitinib 100 mg · Drug: Placebo - 50 mg

  • No intervention
    Synthetic Placebo

    This group will be constructed using participant-level data up to Week 36 from the placebo groups of the appropriately chosen Pfizer clinical studies of Ritlecitinib in participants with alopecia areata and a longitudinal model and extrapolation. This data will be used for comparison between Ritlecitinib 100 mg and placebo at Week 36. As this arm will utilize data from other studies, no participants will be randomized to receive only placebo in this study.

Interventions

  • DrugRitlecitinib 100 mg

    100 mg Capsule

    Also known as: PF-06651600, Litfulo

  • DrugRitlecitinib 50 mg

    50 mg Capsule

    Also known as: PF-06651600, Litfulo

  • DrugPlacebo - 100 mg

    Capsule (to match Ritlecitinib 100 mg)

  • DrugPlacebo - 50 mg

    Capsule (to match Ritlecitinib 50 mg)

06

What researchers measure

Primary outcomes

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

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

    Time frame: Week 24

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

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

    Time frame: Baseline to Follow-up visit (Week 52)

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

    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

    Time frame: Baseline to Follow-up visit (Week 52)

Secondary outcomes

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

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

    Time frame: Week 24

  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"

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

    Time frame: Week 24

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

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

    Time frame: Week 36

  4. Part 1: Change from baseline in SALT score

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

    Time frame: Week 24

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

    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

    Time frame: Week 24

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

    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

    Time frame: Baseline through Week 24

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

    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

    Time frame: Baseline through Week 24

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

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

    Time frame: Baseline through Week 24

  9. Part 1: Change from baseline in SALT score

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

    Time frame: Baseline through Week 24

  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)

    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

    Time frame: Baseline through Week 24

  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)

    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

    Time frame: Baseline through Week 24

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

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

    Time frame: Baseline through Week 24

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

    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

    Time frame: Week 24

  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)

    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

    Time frame: Week 24

  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)

    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

    Time frame: Week 24

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

    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

    Time frame: Week 48

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

    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

    Time frame: Week 48

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

    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

    Time frame: Week 48

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

    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

    Time frame: Week 48

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

    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

    Time frame: Week 24 through Week 48

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

    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

    Time frame: Week 24 through Week 48

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

    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

    Time frame: Week 24 through Week 48

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

    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

    Time frame: Week 24 through Week 48

  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)

    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

    Time frame: Week 24 through Week 48

  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)

    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

    Time frame: Week 24 through Week 48

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

    Percentage of participants with PGI-C 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

    Time frame: Week 24 through Week 48

  27. Part 2: Percentage of participants with absolute SALT score less than or equal to 20

    Percentage of participants with absolute SALT score less than or equal to 20 for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  28. Part 2: Percentage of participants with absolute SALT score less than or equal to 10

    Percentage of participants with absolute SALT score less than or equal to 10 for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  29. Part 2: Percentage of participants with absolute SALT score equal to 0

    Percentage of participants with absolute SALT score equal to 0 for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  30. Part 2: Change from baseline in SALT score

    Mean change from baseline in SALT score for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  31. Part 2: 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)

    Percentage of participants with EBA response for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  32. Part 2: 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)

    Percentage of participants with ELA response for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  33. Part 2: Percentage of participants with PGI-C response, defined as a score of "moderately improved" or "greatly improved"

    Percentage of participants with PGI-C response for ritlecitinib 100 mg QD

    Time frame: Baseline through Week 48

  34. Part 1: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation

    Percentage of participants with events, based on those reported in the study including the safety follow-up period for ritlecitinib 100 mg QD and ritlecitinib 50 mg

    Time frame: Baseline to Follow-up visit (Week 52)

  35. Part 1: Percentage of participants with clinically significant laboratory abnormalities

    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 and ritlecitinib 50 mg

    Time frame: Baseline to Follow-up visit (Week 52)

07

Study locations

41 of 148 sites recruiting
  • The Kirklin Clinic of UAB Hospital (Radiology)
    Birmingham, Alabama 35233, United States
    Recruiting
  • University of Alabama at Birmingham Faculty Office Towers (Regulatory)
    Birmingham, Alabama 35233, United States
    Recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
    Recruiting
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas 71913, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Doc1 Healthcare Systems
    Brea, California 92821, United States
    Recruiting
  • California Dermatology & Clinical Research Institute
    Encinitas, California 92024, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Marvel Clinical Research
    Huntington Beach, California 92647, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of California - Irvine
    Irvine, California 92617, United States
    Recruiting
  • Gavin Herbert Eye Institute
    Irvine, California 92697, United States
    Recruiting
  • Southern California Clinical Research
    Santa Ana, California 92701, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Brett King MD, LLC
    Fairfield, Connecticut 06824, United States
    Recruiting
  • Alliance for Multispecialty Research, LLC
    Fort Myers, Florida 33912, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Robert B. Pritt, DO, PA
    Fort Myers, Florida 33912, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Pediatric Skin Research
    Miami, Florida 33156, United States
    Recruiting
  • Skin Research of South Florida
    Miami, Florida 33173, United States
    Recruiting
  • ForCare Clinical Research
    Tampa, Florida 33613, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Olympian Clinical Research - Tampa - Memorial Highway
    Tampa, Florida 33615, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Endeavor Health Audiology -CHICAGO
    Chicago, Illinois 60625, United States
    Recruiting
  • Endeavor Health Audiology -LAKE BLUFF
    Lake Bluff, Illinois 60044, United States
    Recruiting
  • Endeavor Health Audiology-NORTHBROOK
    Northbrook, Illinois 60062, United States
    Recruiting
  • Endeavor Health Audiology-SKOKIE
    Skokie, Illinois 60076, United States
    Recruiting
  • Endeavor Health Imaging & Radiology Serviccs - Old Orchard
    Skokie, Illinois 60077, United States
    Recruiting
  • Endeavor Health Lab Services - Old Orchard
    Skokie, Illinois 60077, United States
    Recruiting
  • Endeavor Health
    Skokie, Illinois 60077, United States
    Recruiting
  • Dawes Fretzin Clinical Research Group, LLC
    Indianapolis, Indiana 46250, United States
    Recruiting
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
  • Johns Hopkins University
    Baltimore, Maryland 21218, United States
    Recruiting
  • Callender Center for Clinical Research
    Glenn Dale, Maryland 20769, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dermatology and Skin Cancer Specialists, LLC
    Rockville, Maryland 20850, United States
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The General Hospital Corporation d/b/a Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Revival Research Institute, LLC
    Troy, Michigan 48084, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Minnesota Clinics and Surgery Center Department of Radiology
    Minneapolis, Minnesota 55454, United States
    Recruiting
  • University of Minnesota Clinics and Surgery Center Department of Audiology
    Minneapolis, Minnesota 55455, United States
    Recruiting
  • University of Minnesota Clinics and Surgery Center Department of Radiology
    Minneapolis, Minnesota 55455, United States
    Recruiting
  • University of Minnesota Health Clinical Research Unit (M Health CRU)
    Minneapolis, Minnesota 55455, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
  • UNC Dermatology and Skin Cancer Center
    Chapel Hill, North Carolina 27516, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinical & Translational Research Center (CTRC)
    Chapel Hill, North Carolina 27599, United States
    Active, not recruiting

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  • DJL Clinical Research, PLLC
    Charlotte, North Carolina 28211, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Bexley Dermatology Research
    Bexley, Ohio 43209, United States
    Recruiting
  • Apex Clinical Research Center - Canton
    Canton, Ohio 44718, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Vital Prospects Clinical Research Institute, PC
    Tulsa, Oklahoma 74136, United States
    Recruiting
  • Oregon Medical Research Center
    Portland, Oregon 97201, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Northwest Dermatology Institute
    Portland, Oregon 97210, United States
    Active, not recruiting

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  • NW Dermatology Institute
    Portland, Oregon 97210, United States
    Active, not recruiting

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  • Dermatology Associates of Plymouth Meeting
    Plymouth Meeting, Pennsylvania 19462, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
    Charleston, South Carolina 29425, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Alliance for Multispecialty Research, LLC
    Myrtle Beach, South Carolina 29588, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Arlington Research Center
    Arlington, Texas 76011, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The University of Texas Health Science Center at Houston
    Bellaire, Texas 77401, United States
    Not yet recruiting
  • Dermatology Treatment and Research Center
    Dallas, Texas 75230, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Center for Clinical Studies
    Houston, Texas 77004, United States
    Recruiting
  • Texas Dermatology and Laser Specialists
    San Antonio, Texas 78218, United States
    Recruiting
  • Center for Clinical Studies - Clear Lake
    Webster, Texas 77598, United States
    Recruiting
  • AMR Clinical
    Layton, Utah 84041, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Utah
    Murray, Utah 84107, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dermatology Specialists of Spokane
    Spokane, Washington 99202, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Principle Research Solutions
    Spokane, Washington 99202, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dermatology Research Institute
    Calgary, Alberta T2J 7E1, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CaRe Clinic
    Red Deer, Alberta T4P 1K4, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Wiseman Dermatology Research Inc.
    Winnipeg, Manitoba R3M 3Z4, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • SimcoDerm Medical and Surgical Dermatology Center
    Barrie, Ontario L4M 7G1, Canada
    Active, not recruiting

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  • Guelph Dermatology Research
    Guelph, Ontario N1L 0B7, Canada
    Active, not recruiting

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  • DermEffects
    London, Ontario N6H 5L5, Canada
    Active, not recruiting

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  • Lynderm Research Inc.
    Markham, Ontario L3P 1X3, Canada
    Active, not recruiting

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  • Ryan Clinical Research Inc.
    Newmarket, Ontario L3Y 5G8, Canada
    Active, not recruiting

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  • The Centre for Clinical Trials
    Oakville, Ontario L6J 7W5, Canada
    Active, not recruiting

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  • JRB Research Inc.
    Ottawa, Ontario K1K 4L2, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • SKiN Centre for Dermatology
    Peterborough, Ontario K9J 5K2, Canada
    Active, not recruiting

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  • Dermatology on Bloor - Research Toronto
    Toronto, Ontario M4W 2N4, Canada
    Active, not recruiting

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  • Centre de Recherche Saint-Louis
    Montreal, Quebec H1Y 3L1, Canada
    Active, not recruiting

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  • Innovaderm Research Inc.
    Montreal, Quebec H2X 2V1, Canada
    Active, not recruiting

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  • Centre de Recherche Saint-Louis
    Sherbrooke, Quebec J1G 1X9, Canada
    Active, not recruiting

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  • Centre de Recherche Saint-Louis
    Québec, G1V 3V9, Canada
    Active, not recruiting

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  • Centre de Recherche Dermatologique du Quebec metropolitain
    Québec, G1V 4X7, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Centre de Recherche Saint-Louis inc.
    Québec, G1W 4R4, Canada
    Active, not recruiting

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  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
    Active, not recruiting

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  • Beijing Children's hospital, Capital Medical University
    Beijing, Beijing Municipality 100032, China
    Active, not recruiting

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  • Peking University People's Hospital
    Beijing, Beijing Municipality 100044, China
    Active, not recruiting

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  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100192, China
    Active, not recruiting

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  • The Second Affiliated Hospital Chongqing Medical University
    Chongqing, Chongqing Municipality 400010, China
    Active, not recruiting

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  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510120, China
    Active, not recruiting

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  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong 510140, China
    Active, not recruiting

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  • Xiangya Hospital Central South University
    Changsha, Hunan 410008, China
    Active, not recruiting

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  • Jiangxi Provincial Children's Hospital
    Nanchang, Jiangxi, China
    Active, not recruiting

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  • Huashan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200040, China
    Active, not recruiting

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  • Chengdu second people's hospital
    Chengdu, Sichuan 610017, China
    Active, not recruiting

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  • First Affiliated Hospital of Kunming Medical University
    Kunming, Yunnan 650032, China
    Active, not recruiting

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  • Hangzhou Third Hospital
    Hangzhou, Zhejiang 310009, China
    Recruiting
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310016, China
    Active, not recruiting

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  • Beijing Friendship hospital, Capital Medical University
    Beijing, 100050, China
    Active, not recruiting

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  • Beijing Tongren Hospital affiliated to Capital Medical University
    Beijing, 100730, China
    Active, not recruiting

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  • Nanjing Medical University (NMU) - Jiangsu Province Hospital
    Nanjing, 210029, China
    Active, not recruiting

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  • Shanghai Children's Hospital
    Shanghai, 200062, China
    Recruiting
  • Fakultni Nemocnice Plzen
    Pilsen, Plzeň Region 301 00, Czechia
    Active, not recruiting

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  • Kozni ambulance Fialova s.r.o
    Prague, Praha 6 160 00, Czechia
    Active, not recruiting

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  • Pratia Czech s.r.o.
    Pardubice, 53002, Czechia
    Active, not recruiting

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  • Kurume University Hospital
    Kurume, Fukuoka 830-0011, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

Showing the first 100 of 148 sites across 11 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • King B, McMichael A, Sinclair R, Vano-Galvan S, Wolk R, Woodworth D, Soma K, Robbana F, Lejeune A, Napatalung L, Law E, Wajsbrot D, Wang C, Roychoudhury S. Rationale and Design of a Novel, Phase 3, External and Synthetic Placebo-Controlled Clinical Trial of Ritlecitinib 50 mg and 100 mg for Alopecia Areata. Dermatol Ther (Heidelb). 2025 Dec;15(12):3793-3803. doi: 10.1007/s13555-025-01543-7. Epub 2025 Oct 14. PubMed 41083802 ↗

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Mar 2028, 35 months after the start.

Of 20 phase 3 interventional studies under Alopecia Areata, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 46. This study's planned 35 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 13, 2025
StartActual
Apr 1, 2025
Primary completionEst.
Mar 19, 2028
CompletionEst.
Mar 19, 2028
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added, 1 site removed. 13 sites changed recruiting status (13 now recruiting)
Show 13 sites
  • Endeavor Health Audiology -CHICAGO · Chicago, United StatesActive, not recruiting→Recruiting
  • Endeavor Health Audiology -LAKE BLUFF · Lake Bluff, United StatesActive, not recruiting→Recruiting
  • Endeavor Health Audiology-NORTHBROOK · Northbrook, United StatesActive, not recruiting→Recruiting
  • Endeavor Health Audiology-SKOKIE · Skokie, United StatesActive, not recruiting→Recruiting
  • Endeavor Health Imaging & Radiology Serviccs - Old Orchard · Skokie, United StatesActive, not recruiting→Recruiting
  • Endeavor Health Lab Services - Old Orchard · Skokie, United StatesActive, not recruiting→Recruiting
  • Endeavor Health · Skokie, United StatesActive, not recruiting→Recruiting
  • Icahn School of Medicine at Mount Sinai · New York, United StatesActive, not recruiting→Recruiting
  • Texas Dermatology and Laser Specialists · San Antonio, United StatesActive, not recruiting→Recruiting
  • Hangzhou Third Hospital · Hangzhou, ChinaActive, not recruiting→Recruiting
  • Dankook University Hospital · Cheonan-si, South KoreaActive, not recruiting→Recruiting
  • Jeonbuk National University Hospital · Jeonju, South KoreaActive, not recruiting→Recruiting
  • Konkuk University Medical Center · Seoul, South KoreaActive, not recruiting→Recruiting
Show 3 added (1 China, 1 Poland, 1 Taiwan)
  • The First Affiliated Hospital of Guangzhou Medical University · Guangzhou, China
  • Penta Hospitals Badania Kliniczne sp. z o.o. · Gdansk, Poland
  • Chang Gung Memorial Hospital at Kaohsiung · Kaohsiung Niao Sung Dist, Taiwan
Show 1 removed
  • Centrum Badan Klinicznych PI-House sp. z o.o. · Gdansk, Poland
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    3 sites added, 1 site removed. 13 sites changed recruiting status (13 now recruiting)
    Show 13 sites
    • Endeavor Health Audiology -CHICAGO · Chicago, United StatesActive, not recruiting→Recruiting
    • Endeavor Health Audiology -LAKE BLUFF · Lake Bluff, United StatesActive, not recruiting→Recruiting
    • Endeavor Health Audiology-NORTHBROOK · Northbrook, United StatesActive, not recruiting→Recruiting
    • Endeavor Health Audiology-SKOKIE · Skokie, United StatesActive, not recruiting→Recruiting
    • Endeavor Health Imaging & Radiology Serviccs - Old Orchard · Skokie, United StatesActive, not recruiting→Recruiting
    • Endeavor Health Lab Services - Old Orchard · Skokie, United StatesActive, not recruiting→Recruiting
    • Endeavor Health · Skokie, United StatesActive, not recruiting→Recruiting
    • Icahn School of Medicine at Mount Sinai · New York, United StatesActive, not recruiting→Recruiting
    • Texas Dermatology and Laser Specialists · San Antonio, United StatesActive, not recruiting→Recruiting
    • Hangzhou Third Hospital · Hangzhou, ChinaActive, not recruiting→Recruiting
    • Dankook University Hospital · Cheonan-si, South KoreaActive, not recruiting→Recruiting
    • Jeonbuk National University Hospital · Jeonju, South KoreaActive, not recruiting→Recruiting
    • Konkuk University Medical Center · Seoul, South KoreaActive, not recruiting→Recruiting
    Show 3 added (1 China, 1 Poland, 1 Taiwan)
    • The First Affiliated Hospital of Guangzhou Medical University · Guangzhou, China
    • Penta Hospitals Badania Kliniczne sp. z o.o. · Gdansk, Poland
    • Chang Gung Memorial Hospital at Kaohsiung · Kaohsiung Niao Sung Dist, Taiwan
    Show 1 removed
    • Centrum Badan Klinicznych PI-House sp. z o.o. · Gdansk, Poland
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06873945
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Apr 1, 2025
Primary completion
Mar 19, 2028 (estimated)
Completion
Mar 19, 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: PF-06651600

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