Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Tufts Medical Center
- Study ID
- NCT04306965
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Apremilast — DRUG30 mg twice daily (BID)
Study Details
Open label phase 2 investigational study of efficacy and safety of apremilast 30 mg twice a day (BID) in chronic atopic dermatitis when added to the FDA approved treatment dupilumab for atopic dermatitis that is not providing adequate clinical responses.
Key Dates
- First listed
- Mar 13, 2020
- Start date
- Aug 1, 2020
- Status verified
- Apr 2024
- Primary completion
- Jun 23, 2022
- Completion
- Aug 18, 2022
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ApremilastApremilast will be administered to patients as 30 mg oral tablets taken twice daily for 24 weeks. An initial 5-day titration will be implemented to improve tolerability.
Primary Outcome Measure
Proportion of Patients Who Achieve an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16. [ Time Frame: week 16 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tufts Medical Center, Department of Dermatology | Boston | Massachusetts | 02111 | - |
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