CTIS2023-505804-42-00Active, not recruitingPhase 1
B7981041: A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO - B7981041
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Pfizer Inc.
- Enrollment
- 490
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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