A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris

Incyte Corporation0 sites18 target enrollmentOctober 1, 2018

Overview

No summary available.

Registry

who.int

Start Date

October 1, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Men and women aged 18 to 80 years at the time of consent.
•2\.Clinically documented and confirmed diagnosis of pemphigus vulgaris:
•a)Minimum of 6 months of pemphigus vulgaris diagnosis
•b)Positive for anti\-DSG1 or DSG\-3
•c)PDAI score of 8 to 45 points
•d)Have active skin, scalp, or mucosal lesions
•3\.Participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment. There is no limit to the number of prior treatment regimens.
•4\.Willingness to avoid pregnancy or fathering children based on the criteria below.
•a)Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed.
•b)Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow\-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.

•1\.Pregnant or breast\-feeding female.
•2\.Participants with pemphigus vulgaris who are treatment\-naive.
•3\.Use of the following medications within the following periods before baseline:
•i)Potent systemic CYP3A4 inhibitors and inducers or fluconazole. Note: Topical agents with limited systemic availability are permitted. Recommend to consult with medical monitors.
•ii)Topical treatment of pemphigus vulgaris lesions that may affect the disease assessment activities (eg, corticosteroids or tacrolimus/pimecrolimus).
•b)4 weeks: Systemic immunosuppressive (eg, cyclophosphamide and methotrexate), etanercept, anakinra, prednisone \> 0\.5 mg/kg per day (or oral corticosteroid equivalent dose).
•c)12 weeks or 5 half\-lives (whichever is longer): infliximab, adalimumab, golimumab, abatacept, tocilizumab, certolizumab, secukinumab, IVIG, plasmapheresis, or any other biologic or experimental treatment.
•d)12 months: Anti\-CD20 monoclonal antibody, for example, rituximab and ofatumumab.
•4\.Evidence or history of clinically significant infection or medical condition including the following:
•a)Any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with the course, severity, or assessments of pemphigus vulgaris.