Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

NCT05128383 | Completed Phase 2 FDA Drug

• 1 other identifier: 2021P000648
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study investigates the efficacy and safety of dupilumab in the treatment of keloids

Conditions

Keloid

Keywords

keloid; keloid scar; hypertrophic scar; scar

Outcome Measures

Primary Outcomes (1)

• Patient and Observer Scar Assessment Scale (POSAS)

  Average patient scores for Patient and Observer Scar Assessment Scale (POSAS) from baseline and week 24. The POSAS measures scar quality by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer (investigator) and patients. POSAS is comprised of two numeric scales: the Patient Scar Assessment Scale (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60).

  Baseline and Week 24

Secondary Outcomes (4)

• Vancouver Scar Scale (VSS).

  Baseline and Week 24

• Dermatology Life Quality Index (DLQI).

  Baseline and Week 24

• Histology

  Baseline and Week 24

• Number of patients with keloid volume and size improvement

  Baseline and Week 24

Study Arms (1)

Dupilumab Subcutaneous Injection

EXPERIMENTAL

600 mg at initial visit and 300mg every 2 weeks until week 22 Each subject will receive 600mg of Dupilumab at baseline visit and 300mg of Dupilumab as a subcutaneous injection every 2 weeks for a total of 9 doses over 22 weeks.

Drug: Dupilumab

Interventions

Dupilumab DRUG

Dupilumab a human monoclonal antibody of the immunoglobulin G4 subclass that inhibits interleukin (IL)-4 and IL-13 signaling by specifically binding to the IL-4 receptor alpha subunit, which is shared by the IL-4 and IL-13 receptor complexes.

Also known as: Dupixent

Dupilumab Subcutaneous Injection

Eligibility Criteria

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

You may qualify if:

• Men and women between the ages of 18 and 65 at the time of dupilumab initiation.
• Subjects must have either one keloid with ≥ 2 cm length-wise or at least two keloids with ≥ 0.4 cm (width) x 0.4 cm (length)
• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.

You may not qualify if:

• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening.
• Known infection with HIV, hepatitis B or hepatitis C at screening.
• Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential"
• Previous hypersensitivity reaction to dupilumab.
• Patients with acute asthma, acute bronchospasm or status asthmaticus.
• Patients with known helminth infections.
• Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit.
• Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
• Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.
• Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy.
• Has had a live vaccine

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic; Cicatrix

Interventions

dupilumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Martina Porter, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 22, 2021
• Study Start: January 13, 2023
• Primary Completion: May 19, 2025
• Study Completion: June 10, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)