Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06873945 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: ALLEGRO-100
StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Dec 21, 2026 → Mar 19, 2028
Enrollment reduced 49% 1330 → 674 participants
Primary endpoints added 1 → 3 primary endpoints
See other at-risk trials from Pfizer

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 1330 → 674 participants
  2. Study sites: 147 to 146
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 14 of 35 entries
    • Publications: details revised at 1 of 1 entry
  3. Primary and study completion pushed from Dec 21, 2026 to Mar 19, 2028v7 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reopened
    • Enrollment increased: 550 → 1330 participants
    • Trial sites expanded: 143 → 147 locations
    • Trial arms changed: 4 → 5
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 25 to 35
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 114 to 143
    • Primary and study completion dates: Mar 9, 2027 to Dec 21, 2026
    v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 89 to 114v4
  2. Study sites: 22 to 89v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date changed from estimate of Mar 19, 2025 to Apr 1, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pfizer
436 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT06873945
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Alopecia Areata
Related terms Alopecia, Alopecia Areata, Alopecia universalis, Hair Diseases
Enrollment 674 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov