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

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: Apremilast
    Apremilast 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)

FacilityCityStateZIPSite coordinators
Tufts Medical Center, Department of DermatologyBostonMassachusetts02111-

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