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Monoclonal Antibodies
Dupilumab for Keloids
Phase 4
Waitlist Available
Led By Emma Guttman, MD PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects ≥ 18 years of age at the time of signing the informed consent document
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 16, 24, 48, and 52
Awards & highlights
Study Summary
This trial is testing a new treatment for keloids (scar tissue) to see if it is better than a placebo. The trial will include 44 people with keloids, and half of them will also have an allergic/inflammatory disease. The treatment will be given weekly for 24 weeks, and then all subjects will receive the treatment for another 28 weeks.
Who is the study for?
Adults with keloid scars that didn't improve after minimal treatments like creams and injections can join this trial. They must be in good health, understand the study, and follow its schedule. Women who can have children need a negative pregnancy test and must use effective birth control. People with HIV, hepatitis B or C, serious diseases, recent cancer (except certain skin/cervical cancers), previous dupilumab treatment, or recent live vaccines cannot participate.Check my eligibility
What is being tested?
The trial is testing Dupilumab against a placebo to treat keloids. Initially, participants are randomly assigned to receive either Dupilumab or placebo weekly for 24 weeks; then all get Dupilumab until week 52. The study aims to see if Dupilumab helps reduce keloid size compared to no active treatment.See study design
What are the potential side effects?
Dupilumab may cause side effects such as allergic reactions at the injection site, eye irritation or inflammation (pink eye), cold sores in your mouth or on your lips, and rarely more serious allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older and have signed the consent form.
Select...
I am using a highly effective birth control method.
Select...
This criterion does not apply to me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 4, 16, 24, 48, and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 16, 24, 48, and 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in dimensions of keloid lesions at 24 weeks
Secondary outcome measures
Change from baseline in dimensions of keloid lesions at weeks 4, 16, 24, 48, and 52 of treatment with dupilumab
Other outcome measures
Body Surface Area (BSA) affected with disease
Dermatology Life Quality Index (DLQI)
Eczema Area and Severity Index (EASI) score
+4 moreSide effects data
From 2021 Phase 4 trial • 188 Patients • NCT040333679%
Conjunctivitis
7%
Headache
3%
Dermatitis Atopic
2%
Nasopharyngitis
1%
Accidental Overdose
1%
Drug Hypersensitivity
1%
Polyarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
OLE Period: Placebo/Dupilumab
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Dupilumab/Dupilumab
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DupilumabExperimental Treatment1 Intervention
dupilumab 600mg loading dose at Baseline (given as two 300 mg injections) followed by one 300mg weekly subcutaneous injection through Week 52.
Group II: PlaceboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
2017
Completed Phase 4
~12230
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,242 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,803 Total Patients Enrolled
2 Trials studying Keloid
68 Patients Enrolled for Keloid
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,436 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have at least two keloids not fully treated by creams or injections, and one hasn't had surgery or other deforming treatments.I have been treated with dupilumab before.I have used specific skin creams on my keloid scars within the last week.I have a confirmed diagnosis of an allergic condition like asthma or food allergy.I have not received a live vaccine in the last 30 days.I am using or plan to use anti-retroviral therapy during the study.I have or might have a blood cancer, or had another cancer in the last 5 years, except for certain skin and cervical cancers.I haven't taken any strong immune system suppressing drugs in the last 4 weeks.I am 18 years or older and have signed the consent form.I do not have any major health issues that could affect my participation in the study.I am currently pregnant or breastfeeding.I haven't had serious infections or needed antibiotics in the last 2 weeks.I use a condom and an additional barrier method for contraception.I have or had HIV, immunodeficiency, hepatitis B or C, or tuberculosis.I am using a highly effective birth control method.This criterion does not apply to me.I have not taken JAK inhibitors like tofacitinib or ruxolitinib in the last 12 weeks.I have severe asthma or have had life-threatening asthma attacks despite treatment.I am not pregnant and will use birth control during and after the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently seeking test subjects for this trial?
"Clinicaltrials.gov indicates that this trial, which was first made available on May 11th 2021 and most recently updated on August 16th 2022, is actively recruiting participants."
Answered by AI
What ailments has Dupilumab been found to effectively ameliorate?
"Dupilumab has been clinically shown to help alleviate symptoms related to dermatitis, atopic conditions, corticosteroid therapy failure and eosinophilia."
Answered by AI
Has Dupilumab obtained the seal of approval from the FDA?
"Dupilumab has been approved for use, so it is given a safety rating of 3."
Answered by AI
What is the cap for participants in this clinical exploration?
"Affirmative. The information on clinicaltrials.gov affirms that this medical study, which was first posted on 11th May 2021, is presently recruiting patients. A total of 44 participants need to be enlisted from a single site."
Answered by AI
Are there any other experimental trials involving the use of Dupilumab?
"Dupilumab is currently being studied in 49 different trials. Of those, 13 are classified as Phase 3 studies and originate from Palo Alto, California. An extensive network of 2,602 medical sites have been established for the testing of this medication across the globe."
Answered by AI
Has this experiment been tested previously?
"Dupilumab has been the subject of clinical research since 2015 when Sanofi conducted an inaugural trial with 880 participants. Following its Phase 3 approval, Dupilumab is now being studied in 49 active trials spanning 436 cities and 43 countries."
Answered by AI
Who else is applying?
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I have been battling with a hypertrophic scar for over 15years with has emerged into a large keloid on my chest region.I was injected with a steroid injection (Trisolonone)which cleared it initially and now the keloid has grown bigger n it’s spreading round my chest region n curses a lot of discomfort Especially at night.
PatientReceived 1 prior treatment
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