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Monoclonal Antibodies
Dupilumab for Keloids
Phase 2
Recruiting
Led By Martina Porter, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 24
Awards & highlights
Study Summary
This trial looks at whether the medication dupilumab is effective and safe in treating keloids.
Who is the study for?
This trial is for men and women aged 18-65 with keloids, who can understand the study requirements and consent to participate. They must have at least one large keloid or multiple smaller ones but cannot be pregnant, breastfeeding, or planning pregnancy during the study. Participants should not be on immunosuppressants, have chronic infections including HIV/Hepatitis B/C, or a history of hypersensitivity to dupilumab.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of a medication called Dupilumab in treating keloids—overgrown scars that rise above the skin surface. The study will involve participants receiving Dupilumab under controlled conditions to see how well it works and what side effects may occur.See study design
What are the potential side effects?
While specific side effects for this trial are not listed, Dupilumab commonly causes reactions at the injection site, eye inflammation or irritation, headache, oral herpes symptoms among others. Each person's experience with side effects may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and follow the study's requirements and have signed the consent form.
Select...
I have a keloid larger than 2 cm or at least two keloids each bigger than 0.4 cm.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient and Observer Scar Assessment Scale (POSAS)
Secondary outcome measures
Dermatology Life Quality Index (DLQI).
Histology
Number of patients with keloid volume and size improvement
+1 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
1Treatment groups
Experimental Treatment
Group I: Dupilumab Subcutaneous InjectionExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,214 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
616 Previous Clinical Trials
379,825 Total Patients Enrolled
2 Trials studying Keloid
92 Patients Enrolled for Keloid
Martina Porter, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any immunosuppressant drugs or haven't taken any in the last 28 days.I do not have HIV, hepatitis B, or hepatitis C.I am a woman who can get pregnant and agree to use birth control during and 8 weeks after the study.I can understand and follow the study's requirements and have signed the consent form.I have a keloid larger than 2 cm or at least two keloids each bigger than 0.4 cm.I have a known worm infection.I haven't received any keloid treatments in the last 28 days.I am between 18 and 65 years old.I have a chronic infection or tested positive for tuberculosis.I am currently experiencing a severe asthma attack.I have received a live vaccine recently.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Dupilumab Subcutaneous Injection
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Keloid Patient Testimony for trial: Trial Name: NCT05128383 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some other examples of research done on Dupilumab?
"At the moment, there are 51 active studies researching Dupilumab with 13 trials in Phase 3. Most of the clinical trials for Dupilumab are based Louisville, Kentucky, but 2620 locations worldwide are running clinical trials for Dupilumab."
Answered by AI
How many people will be given the opportunity to try this new treatment?
"Yes, the information on clinicaltrials.gov point out that this study is actively searching for candidates. The clinical trial was first posted on 12/1/2022 and was last updated on 11/2/2022. The study is enrolling 20 patients across 1 sites."
Answered by AI
Are volunteers still needed for this research project?
"The clinical trial is still recruiting patients, as seen on clinicaltrials.gov. This specific study was first posted on December 1st, 2020 and updated November 2nd, 2020."
Answered by AI
Does this research represent a new development in the field?
"Since 2015, Dupilumab has been the focus of clinical research with the first study taking place that year. The sponsor for this initial 880-person study was Sanofi. After Phase 3 approval was granted, there are now 51 active trials in 43 countries and 446 cities."
Answered by AI
Are there any potential risks associated with Dupilumab?
"While Phase 2 trials are not as advanced as Phase 3, meaning there is less data to support safety, our team believes that the Dupilumab drug is safe and gave it a score of 2."
Answered by AI
Might I be eligible to take part in this research?
"20 patients in total will be included in this clinical trial. In order to meet the eligibility requirements, potential participants must have keloid and be between 18-65 years old."
Answered by AI
What are some of the most common conditions that Dupilumab is used to manage?
"Dupilumab is a medication that dermatologists often prescribe to patients with atopic dermatitis. Additionally, it can be used as an intervention for other conditions like corticosteroid-resistant asthma and eosinophilic esophagitis."
Answered by AI
If a patient is 55 years or younger, can they participate in this research project?
"The age range for participants in this particular trial is 18 to 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Maryland
Connecticut
How old are they?
65+
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Just feels like going through the trials, so I have joined this. I am looking for solutions to my various keloids on my scalp and neck areas.
PatientReceived 1 prior treatment
I’ve been going to several dermatologists and none of them have helped me to a great degree. I would like to to see if this can help me. I tried injections dermajets and excisions all had little to no results.
PatientReceived no prior treatments
I have surgical keloid scars, acne scars on my back and chest, and piercing scars on my ears. I have tried steroid shots and creams but the itching and pain have not gone away. Not all my scars have been treated but I have about 14 scars not all might mesure to the size of the trial but some do for certain. They cause me pain and annoyance and self confidence issues any improvement is enough for me. I am only 19 and have these ugly scars on my back and chest and my leg looks like a butcher did my surgeries and my ears look gross.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
I live in Atlanta would travel and housing be covered?
PatientReceived 1 prior treatment
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