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A Phase 3 Study With Randomized Withdrawal/Dose Up Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Participants With Nonsegmental Vitiligo
EU CTIS ID: 2023-505804-42-00
What this study is testing
To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD and ritlecitinib 50 mg QD in adult and adolescent participants with nonsegmental vitiligo
- 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
- Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.
- Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040 can be enrolled (refer to Appendix 15 for definitions of stable and active nonsegmental vitiligo in Study B7981040).
- Must agree to not use any other treatments for vitiligo from Screening through the final follow-up visit. See Section 6.9 for information regarding rescue treatment.
- The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040.
You likely can't join if
- Participant met the parent study (Study B7981040) discontinuation criteria or discontinued the parent study for any safety-related event: Experienced an event requiring discontinuation from Study B7981040 as outlined in the protocol (lab abnormalities, ECG changes, pregnancy, etc) or; Experienced any AEs that in the judgement of the investigator or the sponsor would deem the participant not appropriate for enrollment in the LTE study (any participant with an SAE considered potential event of interest by the adjudication committee should be discussed with the sponsor) or; Experienced any SAEs that are confirmed events of interest by the adjudication/review committee or; Experienced any clinically meaningful decline in hearing from BL in the parent study.
- Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- TB Infection History:Countries in which TB incidence has been reported at a rate of >10 cases per 100,000 persons per WHO or local country epidemiology data only.
- Other Medical Conditions: Other medical conditions which in the opinion of the investigator or Pfizer make the participant inappropriate for entry into this study or unwilling/unable to comply with study procedures and lifestyle requirements; History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention; Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Korea, Republic of
- Australia
- South Africa
- Turkey
- India
- Argentina
- Mexico
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Korea, Republic of; Australia; South Africa; Turkey; India and 3 more location(s). 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.