KeloidPhase 4NCT04988022
Dupilumab in the Treatment of Keloids
A Phase 4 study testing Dupilumab in people with Keloid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 24 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Defining Reversal of Keloid Lesions by Th2 Targeting With Dupilumab Treatment
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.
Read the detailed description
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.
After providing consent, subjects will be assessed for study eligibility during the screening period (within 28 days of Baseline), which includes a review of the subject's past and current medical conditions as well as a family history of keloids, atopic dermatitis (AD), asthma and other atopic diseases, detailed review of past and current medications, review of past topical and systemic treatments/therapies and invasive treatments (including surgery, radiation, and cryotherapy) for keloids, limited physical examination, clinical assessments (number, location and measurements via tonometer and calipers). Measurements of keloid lesions will be standardized and performed using Verneir Calipers. These are accurate to the nearest 0.01mm in their measurement of all dimensions. Keloid distensibility (hardness) will be measured using a tonometer, a tool that has been adapted for use in systemic sclerosis and can give insight into softening of lesions.
Subjects who meet inclusion criteria for eligibility will undergo Baseline assessments at Week 0, including clinical assessments (number, location and measurements via tonometer and calipers), review of concomitant medications, standardized clinical photography, questionnaires (a Dermatology Life Quality Index (DLQI), and a Keloid-Quality of Life Index (K-QLI) questionnaire), and additional skin assessments if he/she concurrently has atopic dermatitis (EASI, IGA, BSA and SCORAD will be used to evaluate existing atopic dermatitis). Blood samples and skin biopsies will be collected for mechanistic studies (described below) at various timepoints for RNA, DNA and protein analyses, as well as for analyses of IgE and serum CRP. Two 4.5 mm biopsies will be performed at Baseline: one from a keloid lesion and one from an adjacent non-lesional area. Non-lesional biopsies will mimic nascent trauma (e.g. surgery, or other inflammatory processes) and evaluate the effectiveness of dupilumab in preventing new keloid lesion formation.
Subjects will return for visits at weeks 4, 8, 16, 24, 28, 36, 48, and 52 following study treatment initiation for repeat clinical assessments (number, location, and measurements via tonometer and calipers), medication reviews, blood and biopsy collection, surveys, and monitoring for adverse events. At week 24 a second lesional biopsy will be performed (from the same keloid area biopsy at baseline, but away from the previous biopsy scar), and at week 48 both a lesional (again from the same keloid, but away from prior biopsies) and a non-lesional biopsy will be performed. Bloods will be done at baseline, week 4, week 16, week 24, week 48. The biopsy sites as well as other lesional areas will be monitored at each subsequent visit by clinical assessment (number, location and measurements via tonometer and calipers) and standardized clinical photography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
300 mg prefilled syringe
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | dupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52. Receives: 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. Receives: Drug: Dupilumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: baseline and weeks 4, 16, 24, 48, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start25 May 2021
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Sanofi
- Responsible party
- Principal investigator, Emma Guttman, Icahn School of Medicine at Mount Sinai
- Investigators
- Emma Guttman, MD PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988022
- Sponsor's protocol ID
- GCO 20-3159
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Reversal of Keloid Lesions by Th2 Targeting With Dupilumab Treatment
- ClinicalTrials.gov ID
- NCT04988022
- Acronym / sponsor ID
- GCO 20-3159
- Conditions
- Keloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals, Sanofi
- Study start
- 25 May 2021 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
After providing consent, subjects will be assessed for study eligibility during the screening period (within 28 days of Baseline), which includes a review of the subject's past and current medical conditions as well as a family history of keloids, atopic dermatitis (AD), asthma and other atopic diseases, detailed review of past and current medications, review of past topical and systemic treatments/therapies and invasive treatments (including surgery, radiation, and cryotherapy) for keloids, limited physical examination, clinical assessments (number, location and measurements via tonometer and calipers). Measurements of keloid lesions will be standardized and performed using Verneir Calipers. These are accurate to the nearest 0.01mm in their measurement of all dimensions. Keloid distensibility (hardness) will be measured using a tonometer, a tool that has been adapted for use in systemic sclerosis and can give insight into softening of lesions.
Subjects who meet inclusion criteria for eligibility will undergo Baseline assessments at Week 0, including clinical assessments (number, location and measurements via tonometer and calipers), review of concomitant medications, standardized clinical photography, questionnaires (a Dermatology Life Quality Index (DLQI), and a Keloid-Quality of Life Index (K-QLI) questionnaire), and additional skin assessments if he/she concurrently has atopic dermatitis (EASI, IGA, BSA and SCORAD will be used to evaluate existing atopic dermatitis). Blood samples and skin biopsies will be collected for mechanistic studies (described below) at various timepoints for RNA, DNA and protein analyses, as well as for analyses of IgE and serum CRP. Two 4.5 mm biopsies will be performed at Baseline: one from a keloid lesion and one from an adjacent non-lesional area. Non-lesional biopsies will mimic nascent trauma (e.g. surgery, or other inflammatory processes) and evaluate the effectiveness of dupilumab in preventing new keloid lesion formation.
Subjects will return for visits at weeks 4, 8, 16, 24, 28, 36, 48, and 52 following study treatment initiation for repeat clinical assessments (number, location, and measurements via tonometer and calipers), medication reviews, blood and biopsy collection, surveys, and monitoring for adverse events. At week 24 a second lesional biopsy will be performed (from the same keloid area biopsy at baseline, but away from the previous biopsy scar), and at week 48 both a lesional (again from the same keloid, but away from prior biopsies) and a non-lesional biopsy will be performed. Bloods will be done at baseline, week 4, week 16, week 24, week 48. The biopsy sites as well as other lesional areas will be monitored at each subsequent visit by clinical assessment (number, location and measurements via tonometer and calipers) and standardized clinical photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Drug: Dupilumabdupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52. |
| Placebo | Placebo comparator | Drug: Dupilumab, Drug: Placebomatching 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: Dupixent300 mg prefilled syringe | Drug | Dupilumab, Placebo |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Change from baseline in dimensions of keloid lesions at 24 weeks
Time frame: baseline and 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.
1 secondary outcome
Change from baseline in dimensions of keloid lesions at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab
Time frame: baseline and weeks 4, 16, 24, 48, and 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Guttman, MD PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dupilumab in people with Keloid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in dimensions of keloid lesions at 24 weeks (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.