BridgeMD
A Long-Term Extension Study to Evaluate the Safety and Efficacy of Ritlecitinib in Participants With Severe AA Who Have Completed Studies B7981027 or B7981031
EU CTIS ID: 2024-515439-31-00
What this study is testing
To evaluate the long-term safety and tolerability of ritlecitinib in pediatric participants with severe AA who have completed the studies B7981027 or B7981031.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- a)For participants originating from Study B7981031: 1.Participants with AA (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the B7981031 study. 2. At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
- b)For participants originating from Study B7981027: 3. Participants with AA (including AT and AU) who completed the B7981027 study.
You likely can't join if
- a)Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1.During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
- 2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.
- b)Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
- 2. Any present malignancies or history of malignancies or lymphoproliferative disorders.
- 3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
- 4. History (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex.
See the full eligibility criteria
- a)For participants originating from Study B7981031: 1.Participants with AA (including alopecia totalis [AT] and alopecia universalis [AU]) who completed the B7981031 study. 2. At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.
- b)For participants originating from Study B7981027: 3. Participants with AA (including AT and AU) who completed the B7981027 study.
- a)Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1.During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
- 2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.
- b)Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with >30 Days between last dose in Study B7981027 and first visit of Study B7981028: 1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.
- 2. Any present malignancies or history of malignancies or lymphoproliferative disorders.
- 3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection.
- 4. History (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex.
- 5. Any infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant within prior 3 months.
- 6. Infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Japan
- Canada
- China
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Japan; Canada; China; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.