RESET Trial - Part 1 - A Phase 3 Trial in Subjects With Sjögren-Larsson Syndrome (SLS)

NCT03445650 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ADX-102-SLS-006
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Sjogren-Larsson Syndrome

Keywords

ADX-102, Sjögren-Larsson Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual Index Ichthyosis Severity (VIIS) Scaling Score as Assessed by the Investigator in ADX-102 Treated Patients

  Change from baseline using the Visual Index Ichthyosis Severity (VIIS) Scaling Score (0 = least, 4 = most), where a higher value represents a worse outcome, in ADX-102 treated patients

  Efficacy assessment period (Week 1 through Week 24), where Baseline is Day 1.

Study Arms (2)

ADX-102 1% Topical Dermal Cream (reproxalap)

EXPERIMENTAL

Drug: ADX-102 1% Topical Dermal Cream (reproxalap)

Vehicle of ADX-102 Topical Dermal Cream

PLACEBO COMPARATOR

Drug: Vehicle of ADX-102 Topical Dermal Cream

Interventions

ADX-102 1% Topical Dermal Cream (reproxalap) DRUG

ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months.

ADX-102 1% Topical Dermal Cream (reproxalap)

Vehicle of ADX-102 Topical Dermal Cream DRUG

Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months.

Vehicle of ADX-102 Topical Dermal Cream

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Visual Index Ichthyosis Severity (VIIS) score.
• Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06519, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Sjogren-Larsson Syndrome

Interventions

reproxalap; Skin Cream

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Skin Diseases, Genetic; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Skin Care; Hygiene; Therapeutics; Cosmetics; Household Products; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 26, 2018
• Study Start: July 18, 2018
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: February 9, 2023
• Results First Posted: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)