A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled,Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo (Selective Treatment of Oral Povorcitinib in Vitili)
D
David Rosmarin
Primary Investigator
Recruiting
18-75 years
All
Phase
3
5 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this Study is to compare the safety and effects of povorcitinib or placebo on people with nonsegmental vitiligo.
Detailed description of study
What will happen during the study?
- The Study consists of a double blind period for 52 weeks.
- In the double blind period of the Study, we will look at how effective and safe the Study Drug is compared to placebo at treating vitiligo.
- After the double blind period, all participants will receive Study Drug for another 52 weeks, this is an open label extension period.
- During this period all participants will have the opportunity to receive the Study Drug and will allow for longer safety data collection.
- Participants completing both the double blind and open label study treatment period may be eligible to participate in a separate rollover study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Nonsegmental vitiligo
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Age: Between 18 Years - 75 Years
-
Gender: All
Inclusion Criteria:
- Aged ≥ 18 years.
- Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
-Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Other forms of vitiligo or skin depigmentation disorders.
- Clinically significant abnormal TSH or free T4 at screening.
- Use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to Day 1.
- Current or past use of the depigmenting agent monobenzyl ether of hydroquinone including Benoquin®.
- History of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo.
- Spontaneous and significant repigmentation within 6 months prior to screening.
- Women who are pregnant, considering pregnancy, or breast feeding.
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; Q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies.
- Evidence of infection with TB, HBV, HCV or HIV.
- History of failure to JAK inhibitor treatment of any inflammatory disease.
- Laboratory values outside of the protocol-defined ranges.
Updated on
11 Sep 2024.
Study ID: DERM-INCYTE-STOP-V2, 22865
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