RESET Trial – Part 1 (Followed by Reset Trial – Part 2) – A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

Overview

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream in Subjects with Sjögren-Larsson Syndrome (SLS).

Full Title of Study: “A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of ADX-102 1% Topical Dermal Cream (Reproxalap) in Subjects With Sjögren-Larsson Syndrome (SLS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • Drug: ADX-102 1% Topical Dermal Cream (reproxalap)
    • ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.
  • Drug: Vehicle of ADX-102 Topical Dermal Cream
    • Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.

Arms, Groups and Cohorts

  • Experimental: ADX-102 1% Topical Dermal Cream (reproxalap)
  • Placebo Comparator: Vehicle of ADX-102 Topical Dermal Cream

Clinical Trial Outcome Measures

Primary Measures

  • Visual Index Ichthyosis Severity (VIIS) Scaling severity score as assessed by the investigator.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Severity of scaling based on the VIIS score system.

Secondary Measures

  • (VIIS) Erythema severity score.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Severity of erythema based on the VIIS score system.
  • Pharmacokinetic profile.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Area under the curve (AUC).
  • Pharmacokinetic profile.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Maximum Plasma Concentration (Cmax).
  • Pharmacokinetic profile.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Time to Maximum Plasma Concentration (Tmax).
  • Pharmacodynamic profile.
    • Time Frame: Efficacy assessment period (Week 1 through Week 24)
    • Transepidermal water loss.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is aged 3 years or older
  • Subject has a genetically-confirmed diagnosis of SLS.
  • Subject has active ichthyosis that is Grade 2 or higher on the VIIS scaling severity score.
  • Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.

Exclusion Criteria

  • Subject has evidence of a serious active infection.
  • Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
  • Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
  • Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
  • Subject has a known allergic reaction to any ingredients of study drug formulation.
  • Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aldeyra Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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