Dupilumab in the Treatment of Keloids

NCT04988022 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: GCO 20-3159
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Change from baseline in dimensions of keloid lesions at 24 weeks

  Change from baseline in dimensions of keloid lesions (length, width, and depth in cm) at 24 weeks of treatment with dupilumab performed using Verneir Calipers.

  baseline and 24 weeks

Secondary Outcomes (1)

• Change from baseline in dimensions of keloid lesions at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab

  baseline and weeks 4, 16, 24, 48, and 52

Other Outcomes (7)

• Dermatology Life Quality Index (DLQI)

  Week 52

• Keloid-Quality of Life Index (K-QLI) questionnaire

  Week 52

• Keloid distensibility

  Week 52

Study Arms (2)

Dupilumab

EXPERIMENTAL

dupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

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.

Drug: Dupilumab; Drug: Placebo

Interventions

Dupilumab DRUG

300 mg prefilled syringe

Also known as: Dupixent

Dupilumab; Placebo

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 18 years of age at the time of signing the informed consent document.
• Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
• Subject is able to adhere to the study visit schedule and other protocol requirements.
• Subject has at least two clinically measurable keloid lesions on the trunk and/or extremities, that failed prior minimally invasive treatments for keloids including topicals and intralesional steroid injections. However, at least one keloid should not have been treated with surgery, cryotherapy, radiation, or any other procedure that leads to a deformity that interferes with proper clinical assessments.
• At least 50% of the subjects: subject has documented diagnosis of concomitant type 2 (atopic/allergic) (e.g., active AD, asthma, chronic rhinosinusitis with nasal polyposis, food allergy confirmed by skin prick test or food allergen specific IgE, seasonal allergies, other confirmed allergies).
• Subject is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
• Option 1: Any one of the following highly effective contraceptive methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
• Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural \[animal\] membrane \[for example, polyurethane\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

You may not qualify if:

• Subject has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth parasitic infections, within 2 weeks of the Screening Visit. Any treatment of such infections must have been completed at least 2 weeks prior to the Screening Visit and no new/recurrent infections should have occurred prior to the Baseline Visit.
• Subject with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e. Common Variable Immunodeficiency \[CVID\]), hepatitis B or C, or active or untreated latent tuberculosis.
• Subject has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases that will affect the health of the subject during the study, or interfere with the interpretation of study results.
• Subject has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.
• Subject was treated previously with dupilumab.
• Subject has received a live attenuated vaccine ≤ 30 days prior to study initiation.
• History of adverse systemic or allergic reactions to any component of the study drug.
• Severe, untreated asthma or a history of life-threatening asthma exacerbations while on appropriate regimen of anti-asthmatic medications.
• Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with or without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to trial initiation.
• Use of an oral JAK inhibitor (tofacitinib, ruxolitinib) within 12 weeks prior to the Baseline visit.
• Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus on any keloid lesions within 1 week prior to the Baseline visit. These will be allowed during the study on areas of atopic dermatitis (if applicable) but not on any keloid lesions.
• Female subject who is pregnant or breast feeding
• Subject currently uses or plans to use anti-retroviral therapy at any time during the study.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Guttman, MD PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 3, 2021
• Study Start: May 25, 2021
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

US (1)