Overview

Dupilumab in the Treatment of Keloids

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Criteria
Inclusion Criteria:

- 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.

OR

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).

Exclusion Criteria:

- 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.