A Randomized Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Subjects With Hypertrophic Scar

NCT02956317 | Completed Phase 1

• 1 other identifier: SRN-705-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, within-subject placebo controlled study to evaluate the safety and efficacy of various doses of STP705 administered as intradermal Injection in subjects with hypertrophic scar. The goals are to determine the recommended Phase 2 dose, the pharmacokinetics and pharmacidynamics parameters, and conduct analysis of biomarkers common to the scar formation pathway.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (1)

• Differences among the 3 dosage Groups in 24 Patients' appearance of the scar from baseline evaluated by Patient and Observer Scar Assessment Scale (POSAS)

  32 weeks

Secondary Outcomes (4)

• Change in appearance of the scar from baseline evaluated by Physician Global Assessment using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.

  32 weeks

• Change in appearance of the scar from baseline evaluated by Physician Scar Assessment using Complete Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits.

  32 weeks

• Change in appearance of the scar from baseline evaluated by Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at T4, T8, FU1, FU2 and FU3 visits

  32 weeks

• Change in volume/size of the scar from baseline evaluated by volumetric measurement using 3D camera at T4, T8, FU1, FU2 and FU3 visits

  32 weeks

Other Outcomes (1)

• Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables

  32 weeks

Study Arms (2)

STP705

ACTIVE COMPARATOR

Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar.

Drug: STP705; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Each subject will receive both active (STP705) and control (Placebo) intradermal injection twice a week for a total of 4 weeks at 20 μg/cm2/day (in Cohort A), 30 μg/cm2/day (in Cohort B) and 40 μg/cm2/day (in cohort C). The total length of linear hypertrophic scar will be divided equally for treatment with STP705 and placebo. STP705 and Placebo will be injected intradermal every 1 cm length on the hypertrophic scar

Drug: STP705; Drug: Placebo

Interventions

STP705 DRUG

The Cotsiranib drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and Cox-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine co-Polymer (HKP) peptide at a ratio of 1:4 in mass weight (siRNA:peptide), which is further formulated into a dry powder drug product. The administration route would be intra-dermal injection.

Also known as: COTSIRANIB

Placebo; STP705

Placebo DRUG

Normal Saline

Placebo; STP705

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is able to understand and willing to conform to the study procedures and has signed the informed consent form (ICF).
• Subject is male or female, between the ages of 18 and 60 years, inclusive.
• Subject with a hypertrophic scar that meet all of the following criteria:
• linear scar, ≥5 to ≤40 cm in length (Cohort A), ≥5 to ≤50 cm in length (Cohort B), ≥5 to ≤60 cm in length (Cohort C)
• present for minimum 6 months and no greater than 24 months
• located anywhere in the body except on the face or front of neck
• resulting from surgical or traumatic injury
• Subject is judged, by the Investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, electrocardiogram, vital signs, and clinical laboratory tests.
• Subject is willing and able to complete the entire course of the trial and to comply with the trial instructions.
• Subject, if female of child-bearing potential, has a negative serum pregnancy test at screening and a negative urine pregnancy test at prior to treatment and willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) throughout the study.

You may not qualify if:

• Subjects identified as having keloid or burn scars
• Subjects who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody and HIV.
• Concurrent use of corticosteroids (including inhaled steroids) and COX-2 inhibitors
• Are immuno-compromised (HIV infected, cancer and other disease affecting the basal immune response)
• Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, or metabolic disease that is, in the opinion of the Investigator, not stabilized or may otherwise impact the results of the study.
• Known allergy or hypersensitivity to the study drug(s) or one of the ingredients of the formulation.
• Any infection or wound in the area to treat.
• Female subjects who are pregnant or breast-feeding.
• Participation in a clinical study involving administration of an investigational compound within the past 30 days.
• Existence of any surgical, medical or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism or excretion of the drug.

Sponsors & Collaborators

• Sirnaomics: lead

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 7, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 24, 2021

Record last verified: 2017-11

Locations

US (1)