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

Beth Israel Lahey Health

Status and phase: Active, not recruiting; Phase 2

Conditions: Keloid

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05128383

2021P000648

Details and patient eligibility

About

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

Full description

Current scar treatments have limited efficacy and are often unsatisfactory although over $20 billion dollars are spent annually on the treatment and management of scars. Keloids, an abnormal proliferation of scar tissue, can be disfiguring, functionally impairing, and have dramatic impacts on quality of life. Treatments of keloids include a variety of modalities (i.e. intralesional steroid injections, silicone gel or sheets, surgery, laser, radiation therapy, cryotherapy, topical imiquimod, and intralesional 5-fluorouracil injections). However, current treatments are limited to primarily localized interventions.

The Investigators hypothesize that dupilumab can decrease the size and symptoms of keloids and improve patient's quality of life. An open-label proof of concept study regarding the use of dupilumab in patients with keloids may be the first step in elucidating a novel systematic approach to treatment of keloids.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dupilumab Subcutaneous Injection

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab