Dupilumab in the Treatment of Keloids

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04988022
Phase
PHASE4
Status
Completed

Conditions

  • Keloid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    300 mg prefilled syringe
  • Placebo — DRUG
    Matching placebo

Study Details

This study is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will include a total of 44 subjects with clinically measurable keloid lesions. At least 50% of subjects (at least 22 out of the 44 subjects) will also have documented diagnosis of concomitant type 2 atopic/allergic) inflammatory diseases. In Phase I, subjects will be randomized (3:1) to either receive weekly dupilumab or placebo for 24 weeks. At Week 24, both groups will enter Phase II of the study in which all subjects will receive weekly doses of dupilumab up to Week 52. The treatment period will conclude at Week 52.

Key Dates

Start date
May 25, 2021
Status verified
Jul 2025
Primary completion
Mar 24, 2025
Completion
Mar 24, 2025

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    dupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.
  • Placebo Comparator: Placebo
    matching placebo loading dose at Baseline (given as two injections) followed by one weekly subcutaneous injection through Week 24. Starting at Week 24, dupilumab 600mg loading dose (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.

Primary Outcome Measure

Change from baseline in dimensions of keloid lesions at 24 weeks [ Time Frame: baseline and 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NY

Related Studies