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Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

Primary Purpose

Keloid

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloid focused on measuring keloid, keloid scar, hypertrophic scar, scar

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women between the ages of 18 and 65 at the time of dupilumab initiation.
  • 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)
  • 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.

Exclusion Criteria:

  • History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening.
  • Known infection with HIV, hepatitis B or hepatitis C at screening.
  • Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential"
  • Previous hypersensitivity reaction to dupilumab.
  • Patients with acute asthma, acute bronchospasm or status asthmaticus.
  • Patients with known helminth infections.
  • Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit.
  • Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
  • Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.
  • Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy.
  • Has had a live vaccine

Sites / Locations

  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab Subcutaneous Injection

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient and Observer Scar Assessment Scale (POSAS)
Average patient scores for Patient and Observer Scar Assessment Scale (POSAS) from baseline and week 24. The POSAS measures scar quality by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer (investigator) and patients. POSAS is comprised of two numeric scales: the Patient Scar Assessment Scale (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60).

Secondary Outcome Measures

Vancouver Scar Scale (VSS).
Average score of patients for Vancouver Scar Scale (VSS) from baseline and week 24. Score Description: The VSS measures four parameters of scars: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable). Vascularity: assessed by looking at the scar at resting and by blanching the scar and observing the rate and amount of blood return Score 0: normal color and capillary refill Score 1: pink scar with a slight increase in the local blood supply Score 2: red scar with a significant increase in the local blood supply Score 3: purple scar with excess local blood supply, scars which are congested and refill slowly or cannot be completely blanched Pigmentation: The skin will be blanched with a piece of plastic to eliminate the effect of vascularity on skin color and compared with normal skin (Score: 0-3)
Dermatology Life Quality Index (DLQI).
Average score patient-reported outcomes based on Dermatology Life Quality Index (DLQI). Score Description: A Quality of Life Score will be calculated based upon the Dermatology Life Quality Index (DLQI). The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) (Appendix 3)12. It has been extensively used in dermatology clinical trials for atopic dermatitis. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Histology
Histology Description: Percentage Intensity of expression of the markers will be measured by an image analysis program for patients who have data for both baseline and week 24.
Number of patients with keloid volume and size improvement
keloid volume and size improvement will be assessed based on photographs taken by Canfield camera analysis software for patients who have data for both baseline and week 24.

Full Information

First Posted
October 26, 2021
Last Updated
July 20, 2023
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05128383
Brief Title
Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids
Official Title
An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study investigates the efficacy and safety of dupilumab in the treatment of keloids
Detailed Description
Current scar treatments have limited efficacy and are often unsatisfactory although over $20 billion dollars are spent annually on the treatment and management of scars. Keloids, an abnormal proliferation of scar tissue, can be disfiguring, functionally impairing, and have dramatic impacts on quality of life. Treatments of keloids include a variety of modalities (i.e. intralesional steroid injections, silicone gel or sheets, surgery, laser, radiation therapy, cryotherapy, topical imiquimod, and intralesional 5-fluorouracil injections). However, current treatments are limited to primarily localized interventions. The Investigators hypothesize that dupilumab can decrease the size and symptoms of keloids and improve patient's quality of life. An open-label proof of concept study regarding the use of dupilumab in patients with keloids may be the first step in elucidating a novel systematic approach to treatment of keloids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
keloid, keloid scar, hypertrophic scar, scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab Subcutaneous Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent
Intervention Description
Dupilumab a human monoclonal antibody of the immunoglobulin G4 subclass that inhibits interleukin (IL)-4 and IL-13 signaling by specifically binding to the IL-4 receptor alpha subunit, which is shared by the IL-4 and IL-13 receptor complexes.
Primary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS)
Description
Average patient scores for Patient and Observer Scar Assessment Scale (POSAS) from baseline and week 24. The POSAS measures scar quality by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer (investigator) and patients. POSAS is comprised of two numeric scales: the Patient Scar Assessment Scale (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60).
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Vancouver Scar Scale (VSS).
Description
Average score of patients for Vancouver Scar Scale (VSS) from baseline and week 24. Score Description: The VSS measures four parameters of scars: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable). Vascularity: assessed by looking at the scar at resting and by blanching the scar and observing the rate and amount of blood return Score 0: normal color and capillary refill Score 1: pink scar with a slight increase in the local blood supply Score 2: red scar with a significant increase in the local blood supply Score 3: purple scar with excess local blood supply, scars which are congested and refill slowly or cannot be completely blanched Pigmentation: The skin will be blanched with a piece of plastic to eliminate the effect of vascularity on skin color and compared with normal skin (Score: 0-3)
Time Frame
Baseline and Week 24
Title
Dermatology Life Quality Index (DLQI).
Description
Average score patient-reported outcomes based on Dermatology Life Quality Index (DLQI). Score Description: A Quality of Life Score will be calculated based upon the Dermatology Life Quality Index (DLQI). The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) (Appendix 3)12. It has been extensively used in dermatology clinical trials for atopic dermatitis. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time Frame
Baseline and Week 24
Title
Histology
Description
Histology Description: Percentage Intensity of expression of the markers will be measured by an image analysis program for patients who have data for both baseline and week 24.
Time Frame
Baseline and Week 24
Title
Number of patients with keloid volume and size improvement
Description
keloid volume and size improvement will be assessed based on photographs taken by Canfield camera analysis software for patients who have data for both baseline and week 24.
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women between the ages of 18 and 65 at the time of dupilumab initiation. 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) 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. Exclusion Criteria: History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening. Known infection with HIV, hepatitis B or hepatitis C at screening. Are currently pregnant, breastfeeding, or planning to get pregnant during the study. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential" Previous hypersensitivity reaction to dupilumab. Patients with acute asthma, acute bronchospasm or status asthmaticus. Patients with known helminth infections. Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit. Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy. Has had a live vaccine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Jin Chung, MD
Phone
6176675834
Email
hchung6@bidmc.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Porter, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Porter, MD
Phone
617-671-5834
Email
mporter3@bidmc.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

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