A Study for Safety and Efficacy Evaluation of Various Doses of STP705 in Reducing Keloid Recurrence

Study Overview
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Brief Summary
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Phase 2, randomized, double-blind, multiple arm, controlled study to evaluate safety & efficacy of various doses of STP705 in reducing post Keloidectomy keloid recurrence.

Detailed Description
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The objective of this study isto assess the safety, tolerability, and efficacy of various doses of STP705 and placebo via intradermal injection into the keloid excision site, to prevent the recurrence of keloids following their excision. A total of up to 60 adult subjects will be enrolled. One eligible qualifying keloid will be excised. The subjects will be randomized to receive STP705, placebo or SOC alone (no injection) for treatment of the keloidectomy excision suture line. To be eligible, keloid scar(s) must have been present for at least one year with a target keloid area on the trunk or extremity (non-peri-orbital/-anogenital/-scalp), measures ≥0.30cm2, and be suitable for surgical excision which will result in a single wound no greater than 7cm long. The study is divided into 3 phase: screening phase (4 weeks), Treatment phase (up to 4 weeks +/- allowed windows), Follow up phase (up to 52 weeks +/- allowed windows).

Official Title
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A Phase 2, Multi-Center, Randomized, Multiple Arm, Controlled Pilot Study to Evaluate the Safety and Efficacy of Various Doses of STP705 in Reducing Post- Keloidectomy Keloid Recurrence

Conditions
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Keloid

Intervention / Treatment
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* Drug: STP705
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years of age, inclusive having at least one keloid scar. Female subjects of child-bearing potential must agree to the use of an effective method(s) of contraception beginning at or before the screening visit until one month after administration of the final study dose. For the purposes of the protocol, highly effective method(s) of contraception will be defined as consistently and correctly used implants, injectables, combined oral contraceptives, sexual abstinence or a vasectomized partner. The keloid scar(s) must have been present for at least one year with a target keloid area on the trunk or extremity (non-peri-orbital/-anogenital/-facial/-scalp), measures ≥0.30cm2, and be suitable for surgical excision which will result in a single wound no greater than 7cm long. Able and willing to give written informed consent. Willing to comply with the follow up schedule for 12 months. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital sign abnormalities as deemed by the PI. Exclusion Criteria: Prior treatment of the keloid scar in the previous 6 weeks. The keloid scar must not have undergone prior surgical excisions (laser, cryotherapy or surgery). The keloid scar must not have undergone prior radiation treatment. Pregnant, lactating, or planning to become pregnant during the course of the study. Advanced or poorly controlled diabetes. Active local infection at the treatment site and/or systemic infection that would in the opinion of the Investigator affect the treatment site. Any medical or surgical condition that will interfere with required study activities or assessments or that make the study treatments contraindicated in the opinion of the study Investigator. Unwilling to refrain from use of any other scar treatment therapy/scar improving product, during the study. Regular, continuous use of systemic corticosteroid therapy or topical corticosteroid use in the area to be treated. Current participation or participation within the last 1 months in the study of an investigational drug, device, or biologic. Unable or unwilling to follow post-operative instructions. Mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds, or drug product excipients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 subjects each will be randomly allocated to either the assigned STP705 treatment group, placebo or SOC alone in a 1:1:1:1:1:1 ratio. An individual, independent of the clinical trial team, will develop the randomization schedules. The actual randomization assignment will be prepared through a web-based system. STP705 or placebo will be injected intradermally at the keloid excision site.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: STP705 10 μg dose<br>STP705 at the assigned dose will be injected intradermal into the excised keloid site | Drug: STP705<br>* STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively<br>|
| Experimental: Cohort 2: STP705 20 μg dose<br>STP705 at the assigned dose will be injected intradermal into the excised keloid site | Drug: STP705<br>* STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively<br>|
| Experimental: Cohort 3: STP705 30 μg dose<br>STP705 at the assigned dose will be injected intradermal into the excised keloid site | Drug: STP705<br>* STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively<br>|
| Experimental: Cohort 4: STP705 40 μg dose<br>STP705 at the assigned dose will be injected intradermal into the excised keloid site | Drug: STP705<br>* STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA, respectively<br>|
| Placebo Comparator: Cohort 5: Placebo control<br>Placebo (saline) will be injected intradermal into the excised keloid site | Other: Placebo<br>* Saline<br>|
| No Intervention: Cohort 6: SOC alone<br>SOC (no injection) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Recurrence | Rate of recurrence in subjects undergone surgery alone (with or without placebo) vs surgery and STP705 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Keloid volume/size | Change in size of post excision keloid from baseline by volumetric measurements | 12 months | 
| Change of Keloid size | Change of Keloid scar appearance from baseline evaluated by caliper | 12 months | 
| Change of Keloid scar appearance | Change of Keloid scar appearance from baseline evaluated by POSAS | 12 months | 
| Change in DLQI |  | 12 months | 
| Change in VSS score |  | 12 months |