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A Phase 3 Randomized, Double-blind, 52-week Placebo-controlled Multi-center Study With a Double-blind 52-week Extension Period With Randomized Dose up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants With Nonsegmental Vitiligo
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase 3 Randomized, Double-blind, 52-week Placebo-controlled Multi-center Study With a Double-blind 52-week Extension Period With Randomized Dose up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants With Nonsegmental Vitiligo
 
Region Sponsors
California - Northern
Pfizer
 
Acronym NCT No.
NCT06072183
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening. • Meeting reproductive criteria for female participants. Disease Characteristics: Eligible participants must have at both Screening and BL: A clinical diagnosis of nonsegmental vitiligo for at least 3 months
  • and BSA involvement 4% to 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet and BSA =0.5% involvement on the face. Face is defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. Face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids
  • and F-VASI =0.5 and T-VASI =3
  • and Either active or stable nonsegmental vitiligo at Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease. Active vitiligo is defined as: Participants will be classified as having active vitiligo based on the presence of at least one active lesion at BL defined as one of the following: New/extending lesions(s) in the 3 months prior to Screening visit (confirmed by photographs or medical record)
  • Confetti-like lesion(s)
  • Confetti-like depigmentation is characterized by the presence of numerous 1-mm to 5-mm depigmented macules in clusters
 
Exclusion Criteria
  • Any medical or psychiatric condition including recent (within the past year) or 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. Any psychiatric condition including recent or active suicidal ideation or behavior that meets defined criteria. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin: Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criteria (including but not limited to segmental vitiligo and mixed vitiligo).
 
Keywords and/or Specific Medical Conditions
  • Dermatology
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Dermatology


Principal Investigator:
Paradi Mirmirani, MD
Contact Information:
- CTP Team
-ctpcollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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