Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07733765

A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA).

This study is seeking participants who are

* 12 years or older (if permitted by the local IRB/EC and local regulatory health authority) * have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less * do not have any other diseases or conditions affecting hair loss.

Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks.

About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone.

We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Alopecia Areata Alopecia Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Niigata University Medical & Dental Hospital, Niigata, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • 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
  • Have a clinical diagnosis of AA with no other etiology of hair loss.
  • Have >20% to <50% hair loss of the scalp, as measured by SALT.
  • Current AA episode of hair loss ≥6 months and ≤10 years (Current episode is defined as the continuous period of AA-related scalp hair loss since the last time the subject had no visible scalp patches).

Key Exclusion Criteria

  • Diseases or conditions affecting hair loss, including:
  • Other types of alopecia (including, but not limited to, traction and scarring alopecia, telogen effluvium). Participants with androgenetic alopecia will be excluded.
  • Other scalp disease that may impact AA assessment (eg, scalp psoriasis, dermatitis, etc.).
  • Active systemic diseases that may cause hair loss (eg, lupus erythematosus, thyroiditis, systemic sclerosis, lichen planus, etc).

Treatment and study plan

Ritlecitinib 100 mg

Drug

100 mg capsule taken orally once daily

Ritlecitinib 50 mg

Drug

50 mg capsule taken orally once daily

Placebo

Other

Capsule matching either 50mg or 100 mg ritlecitinib capsule taken orally once daily

Primary outcomes

  1. Difference in the proportion of Severity of Alopecia Tool (SALT) 0 responders at Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Week 24

Secondary outcomes

  1. Difference in the proportion of SALT ≤5 responders at Week 24 between ritlecitinib 50 mg QD versus

    Time frame: Week 24

  2. Difference in the proportion of SALT ≤10 responders at Week 24 between ritlecitinib 50 mg QD versus

    Time frame: Week 24

  3. Difference in the proportion of SALT 75 responders at Week 24 between ritlecitinib 50 mg QD versus

    Time frame: Week 24

  4. Difference in the proportion of SALT 90 responders at Week 24 between ritlecitinib 50 mg QD versus

    Time frame: Week 24

  5. Difference in the mean change from baseline (CFB) in SALT score at applicable timepoints through Week 24 for ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18 and 24

  6. Difference in the proportion of Patient Global Impression of Change (PGI-C) responders at Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Week 24

  7. Difference in the proportion of SALT 0 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  8. Difference in the proportion of SALT ≤10 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  9. Difference in the proportion of SALT ≤5 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  10. Difference in the proportion of SALT 75 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  11. Difference in the proportion of SALT 90 responders at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  12. Difference in the mean CFB in SALT score at applicable timepoints between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  13. Difference in the proportion of Eyebrow Assessment (EBA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  14. Difference in the proportion of Eyelash Assessment (ELA) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  15. Difference in the proportion of PGI-C responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18

  16. Difference in the proportion of Patient's Satisfaction with Hair Growth (P-SAT) responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  17. Difference in the proportion of Improvement in hair loss on each of the Alopecia Areata Patient Priority Outcomes (AAPPO) items 1-4 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  18. Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  19. Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints through Week 24 between ritlecitinib 50 mg QD versus placebo

    Time frame: Weeks 8, 12, 18, 24

  20. Proportion of participants with treatment emergent AEs, SAEs, and adverse events leading to discontinuation including those collected during the safety follow-up period

    Time frame: Screening to Follow up period (up to week 57)

  21. Proportion of responders for SALT 0 at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    For each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  22. Proportion of responders for SALT ≤10 at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  23. Proportion of responders for SALT ≤5 at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  24. Proportion of responders for SALT 75 at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  25. Proportion of responders for SALT 90 at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  26. Difference in the proportion of SALT 0 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  27. Difference in the proportion of SALT≤10 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  28. Difference in the proportion of SALT≤5 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  29. Difference in the proportion of SALT75 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  30. Difference in the proportion of SALT90 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  31. Mean CFB in SALT score at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  32. Difference in the mean CFB in SALT score at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  33. Proportion of responders for EBA at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  34. Proportion of responders for ELA at appliable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  35. Difference in the proportion of EBA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  36. Difference in the proportion of ELA responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  37. Proportion of PGI-C responders at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  38. Proportion of P-Sat responders at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  39. Proportion of responders for Improvement in hair loss on each of the AAPPO items 1-4 at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  40. Proportion of responders for Improvement in Emotional Symptoms on each of the AAPPO items 5-8 at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  41. Proportion of responders for Improvement in Activity Limitations on each of the AAPPO items 9-1 1 responders at applicable timepoints after Week 24

    Time frame: Weeks 28, 36, and 48

    for each of the 5 groups (Ritlecitinib 50 mg Responder (R) Group, Ritlecitinib 50 mg NR→50 mg Group, Ritlecitinib 50 mg NR→100 mg Group, Placebo NR→Ritlecitinib 50 mg Group, Placebo R Group)

  42. Difference in the proportion of PGI-C responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  43. Difference in the proportion of P-SAT responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  44. Difference in the proportion of Improvement in hair loss on each of the AAPPO items 1-4 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  45. Difference in the proportion of Improvement in Emotional Symptoms on each of the AAPPO items 5-8 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  46. Difference in the proportion of Improvement in Activity Limitations on each of the AAPPO items 9-11 responders at applicable timepoints after Week 24 between Ritlecitinib 50 mg NR→50 mg Group and Ritlecitinib 50 mg NR→100 mg Group

    Time frame: Weeks 28, 36, and 48

  47. Proportion of participants with clinically significant abnormalities in clinical laboratory test values including those collected during the safety follow-up period

    Time frame: Screening to Follow up period (up to 57 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.