OptiSkin Medical | New York, NY
Status and phase
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Treatments
Study type
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About
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.
Ritlecitinib has been tested in earlier clinical studies and has a favorable safety profile. At present there are no approved medications taken by mouth to treat nonsegmental vitiligo.
This study is seeking participants who:
In this study participants will be chosen by chance, like drawing names out of a hat to receive 1 of 3 treatments:
•Part I where two different amounts of ritlecitinib (50 mg and 100 mg) are taken once daily. It will be compared to placebo. Placebo is a dummy capsule. It doesn't have any medicine used in the study.
Participants receiving placebo who have not responded to treatment after 52 weeks will be given 100 milligrams or 50 milligrams of ritlecitinib for the remaining 52 weeks of the study.
• In Part II, participants will only receive 100 milligrams of ritlecitinib. About 1000 participants will take part in Part I and around 450 in Part II globally. The study will compare the experiences of people receiving ritlecitinib to those of the people who do not. This will help see if ritlecitinib is safe and effective.
People in Part I will be in this study for about 26 months and people in Part II will be in this study for about 14 months. During the study, participants in part I will need to visit the study site at least 17 times. In part II, participants will visit at least 11 times.
Participants will undergo various tests and procedures such as:
Full description
Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo
Enrollment
Sex
Ages
Volunteers
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:
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:
Stable vitiligo is defined as:
• Participants will be classified as having stable vitiligo based on an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) will be classified as having stable disease.
Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.
Additional inclusion criteria are:
Exclusion criteria
Medical Conditions:
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:
General Infection History:
Specific Viral Infection History:
Other Medical Conditions:
Prior/Concomitant Therapy:
Have received any of the prohibited treatment regimens specified.
Prior/Concurrent Clinical Study Experience:
Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 [Baseline] or within 5 half-lives, whichever is longer.
Diagnostic Assessments:
Any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:
Renal impairment
Hepatic dysfunction
Other laboratory abnormalities
Standard 12-lead ECG that demonstrates clinically relevant abnormalities
Other Exclusion Criteria:
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
In South Africa only participants are excluded without one of the following:
Primary purpose
Allocation
Interventional model
Masking
1,450 participants in 4 patient groups, including a placebo group
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Central trial contact
Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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