Keloid Clinical Trial
Official title:
Defining Reversal of Keloid Lesions by Th2 Targeting With Dupilumab Treatment
Verified date | June 2024 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 44 |
Est. completion date | April 2025 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Regeneron Pharmaceuticals, Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dermatology Life Quality Index (DLQI) | Subject quality of life data will be collected using the DLQI which is a 10-item questionnaire, each question is scored from 0 to 3, giving a total possible score range from 0 to 30, higher score indicating poorer health outcome. | Week 52 | |
Other | Keloid-Quality of Life Index (K-QLI) questionnaire | Subject quality of life data will be collected using the K-QLI | Week 52 | |
Other | Keloid distensibility | hardness measured via tonometer | Week 52 | |
Other | Eczema Area and Severity Index (EASI) score | For those with concomitant atopic dermatitis, disease severity assessments will be performed. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity. | Week 52 | |
Other | Investigator Global Assessment (IGA) of disease score | For those with concomitant atopic dermatitis, disease severity assessments will be performed using the 5 point scale ranging from 0=clear to 4=severe disease | Week 52 | |
Other | Body Surface Area (BSA) affected with disease | For those with concomitant atopic dermatitis, body surface area affected with AD will be calculated | Week 52 | |
Other | SCORing Atopic Dermatitis (SCORAD) | For those with concomitant atopic dermatitis, disease severity assessments will be performed. The intensity part of the SCORAD index consists of six items: erythema, edema/papulation, excoriations, lichenification, oozing/crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms. | Week 52 | |
Primary | 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 | Change from baseline in dimensions of keloid lesions at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab | Change from baseline in dimensions of keloid lesions (length, width, and depth in cm) at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab | baseline and weeks 4, 16, 24, 48, and 52 |
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