Study to Evaluate Efficacy of OLX10010 in Reducing Recurrence of Hypertrophic Scarring After Scar Revision Surgery

NCT04877756 | Completed Phase 2 FDA Drug

• 1 other identifier: OLX10010-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly (every two weeks) Arm B: 5.0 mg/cm OLX10010 biweekly (every two weeks) Each treatment arm will have approximately 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery biweekly (every two weeks) for a total of six doses. Dosing will occur post-surgery on Weeks 2, 4, 6, 8, 10, and 12. Post-treatment follow-up visits will occur at Weeks 18 and 24, and a long-term follow-up visit will occur at Month 12. The Patient and Observer Scar Assessment Scale (both physician and patient scales), Stony Brook Scar Evaluation Scale, Vancouver Scar Scale, and a photograph-based visual analog scale by blinded experts will be completed prior to scar revision surgery, at Weeks 2, 8, 12, 18, and 24, and at Month 12. The overall opinion responses on the physician scales of the POSAS at Week 24 will be used for primary endpoint analysis. The total length of the linear hypertrophic scar line will be divided equally for treatment with OLX10010 and placebo, injected intradermally per centimeter (cm). The OLX10010 end and placebo end of the scar line will be separated by a 2 cm or greater distance depending on the scar length. After the Week 24 visit, all data collected will be cleaned and all data management activities will be completed. After the database is frozen/locked, the primary endpoint efficacy analysis will be completed. If at least one of the treatment arms are shown to be appropriate to reduce recurrence of hypertrophic scars, all analyses will be performed. If the efficacy analysis of Arms A and B indicate the study doses are not as effective as expected, the sponsor may decide to add a third arm (Arm C) to explore the weekly dosing regimen. See detailed summary. Subjects in all study arms will continue in the study until their Month 12 visit. After all subjects complete that visit, data are collected, and data management activities are completed, Month 12 data will be analyzed.

Conditions

Hypertrophic Scar

Keywords

scar revision surgery; OLX10010; siRNA

Outcome Measures

Primary Outcomes (1)

• • Change in recurrence of hypertrophic scar after scar revision surgery measured by physician scar assessment using the overall opinion score on the Observer Scar Assessment Scale at Week 24

  • The change of recurrence of hypertrophic scar will be measured by Observer Scar Assessment Scale to rate Vascularity, pigmentation, thickness, relief, pliability, and surface area on a ten point scale with 1 representing normal sensation or skin and 10 indicating the worst imaginable sensation or skin.

  Week 24

Secondary Outcomes (8)

• • Change in the recurrence of hypertrophic scar after scar revision surgery measured by patient scar assessment using the overall opinion score on the Patient Scar Assessment Scale at Week 24

  Week 24

• • Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Physician

  Week 24 and Month 12

• • Recurrence of hypertrophic scar after scar revision surgery at Weeks 2, 8, 12, 18, and 24 and Month 12 according to Patient

  Week 24 and Month 12

• • Scar severity

  Week 24 and Month 12

• • Assessment of Blinded Photographs by Two Independent Assessors:

  Week 24 and Month 12

Study Arms (3)

Arm A 2.0 mg/cm OLX10010 biweekly

EXPERIMENTAL

Arm A- half the scar treated with 2.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo

Drug: OLX10010

Arm B 5.0 mg/cm OLX10010 biweekly

EXPERIMENTAL

Arm B- half the scar treated with 5.0 mg/cm of OLX10010 biweekly, other half treated with OLX Placebo

Drug: OLX10010

Arm C 2.0 mg/cm OLX10010 weekly

EXPERIMENTAL

Arm C- half the scar treated with 2.0 mg/cm of OLX10010 weekly, other half treated with OLX Placebo

Drug: OLX10010

Interventions

OLX10010 DRUG

Lyophilized cake reconstituted with WFI and injected intradermally

Also known as: a cell penetrating asymmetric small interference RNA (cp-asiRNA), targeting a gene involved in formation of fibrosis

Arm A 2.0 mg/cm OLX10010 biweekly; Arm B 5.0 mg/cm OLX10010 biweekly; Arm C 2.0 mg/cm OLX10010 weekly

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females, aged 18 to 65, inclusive
• Hypertrophic scar in the abdominal region, from previous surgery or injury, present for ≥ 12 months
• Linear hypertrophic scar equal to or greater than 8 cm in length
• Undergoing elective hypertrophic scar revision surgery
• Serum pregnancy test negative for females of childbearing potential
• Males and females of child-bearing potential (e.g., not post-menopausal for at least one year or surgically sterile) must agree to use effective contraception starting at the Screening Visit and continuing until 14 days after the last dose of OLX10010.
• Properly obtained written informed consent

You may not qualify if:

• BMI greater than 32 kg/m2. Exceptions to this criteria can be granted for patients just over this value per PI's discretion
• Hypertrophic scars outside the abdominal area, including face, neck, back, limbs, and the thoracic region
• Hypertrophic scar secondary to burns
• Active infection near the scar revision surgery
• Clinically significant wound near the scar revision surgery
• Additional scar(s) within 2 cm of the scar revision surgery
• End-stage renal disease or severe renal impairment as indicated by serum creatinine \> 2.5 mg/dL
• Hypertrophic scar treatment within 12 weeks prior to the screening visit, excluding scar revision surgery
• Radiation or chemotherapy within 12 weeks prior to the screening visit
• Treatment with anti-psychotic, anti-cancer, immunosuppressant, or corticosteroids within 12 weeks prior to the screening visit
• Atopic dermatitis, keloid scar, or skin hypersensitivity
• Received elective body sculpting procedures (e.g., CoolSculpting®) for the abdomen within the past 6 months
• Use of tobacco or nicotine-containing products during study participation (Screening Visit through last follow-up visit)
• Female patients who are pregnant or breastfeeding
• Participation in any experimental drug or device study within 30 days prior to the screening visit

Sponsors & Collaborators

• Olix Pharmaceuticals, Inc.: lead
• Alira Health: collaborator

Study Sites (6)

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Miami Dermatology & Laser Research, LLC

Miami, Florida, 33173, United States

Location

Miami Plastic Surgery

Miami, Florida, 33176, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Paddington Testing Co, Inc.

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• Hwang J, Chang C, Kim JH, Oh CT, Lee HN, Lee C, Oh D, Lee C, Kim B, Hong SW, Lee DK. Development of Cell-Penetrating Asymmetric Interfering RNA Targeting Connective Tissue Growth Factor. J Invest Dermatol. 2016 Nov;136(11):2305-2313. doi: 10.1016/j.jid.2016.06.626. Epub 2016 Jul 15.

  PMID: 27427487 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Neumeister, MD

  OliX Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 parallel arms and then a 3rd arm will be enrolled if the endpoints for the first 2 arms aren't met.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 7, 2021
• Study Start: August 19, 2021
• Primary Completion: January 11, 2023
• Study Completion: July 12, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)