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
Started2025-04-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 14 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

Amendment history

2026-09-19
Enrollment reduced: 1330 → 674 participants
2026-08-11
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Enrollment reopened
Primary endpoint(s) modified1 to 3 entries
WasPercentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20
NowPart 1: Percentage of participants with absolute Severity of Alopecia Tool (SALT) score less than or equal to 20, Part 2: Percentage of participants with TEAEs, SAEs, and AEs leading to discontinuation, Part 2: Percentage of participants with clinically significant laboratory abnormalities
Enrollment increased: 550 → 1330 participants
Trial arms changed: 4 → 5
Trial sites expanded: 143 → 147 locations
Primary completion pushed: 2026-12-21 → 2028-03-19
Completion pushed: 2026-12-21 → 2028-03-19
Eligibility criteria+228 characters
[...] ts 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: Must meet the following alopecia ar [...] cine) at any time during their participation in this study. Receipt of study intervention in Study B7981094 or other studies of ritlecitinib. Diagnostic Assessments: Any exclusionary abnormalities in la [...]
Secondary endpoints25 to 35 entries
Part 1: Percentage of participants with absolute SALT score less than or equal to 20 Change from baseline in SALT score Part 1: EU Only: Percentage of participants with Patient Global Impr [...] d as a score of "moderately improved" or "greatly improved" Part 1: US Only: Percentage of participants with absolute SALT score less than or equal to 20 Part 1: Change from baseline in SALT score Part 1: Percentage of participants with absolute SALT score equal to 0 Part 1: Percentage of participants with absolute SALT score less than or equal to 10 Part 1: Percentage of participants with absolute SALT score [...] [...]
2026-05-08
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations, References v5
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-03-09→2026-12-21
Completion date2027-03-09→2026-12-21
Study sites114→143
2025-09-30
Study Status v4
Re-verified, no change to tracked fields
2025-09-08
Study Status, Contacts/Locations, References v3
Study sites89→114
Show 2 earlier versions
2025-08-11
Study Status, Contacts/Locations v2
Study sites22→89
2025-05-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-19→confirmed 2025-04-01
Study sites0→22
2025-03-07
Original filing
Pfizer
431 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 Alopecia Areata
Enrollment 674 participants
Start Date 2025-04-01
Primary Completion 2028-03-19 (estimated)
Study Completion 2028-03-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-18