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Trial record 3 of 3 for:    aldeyra | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies

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

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ClinicalTrials.gov Identifier: NCT03445650
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Sjogren-Larsson Syndrome Drug: ADX-102 1% Topical Dermal Cream (reproxalap) Drug: Vehicle of ADX-102 Topical Dermal Cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: ADX-102 1% Topical Dermal Cream (reproxalap) 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.

Placebo Comparator: Vehicle of ADX-102 Topical Dermal Cream 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. (VIIS) Erythema severity score. [ Time Frame: Efficacy assessment period (Week 1 through Week 24) ]
    Severity of erythema based on the VIIS score system.

  2. Pharmacokinetic profile. [ Time Frame: Efficacy assessment period (Week 1 through Week 24) ]
    Area under the curve (AUC).

  3. Pharmacokinetic profile. [ Time Frame: Efficacy assessment period (Week 1 through Week 24) ]
    Maximum Plasma Concentration (Cmax).

  4. Pharmacokinetic profile. [ Time Frame: Efficacy assessment period (Week 1 through Week 24) ]
    Time to Maximum Plasma Concentration (Tmax).

  5. Pharmacodynamic profile. [ Time Frame: Efficacy assessment period (Week 1 through Week 24) ]
    Transepidermal water loss.



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445650


Contacts
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Contact: Carolyn Soo, Pharm. D. 781-761-4904 csoo@aldeyra.com

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Keith A. Choate, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: William B. Rizzo, MD         
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.

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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03445650     History of Changes
Other Study ID Numbers: ADX-102-SLS-006
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aldeyra Therapeutics, Inc.:
ADX-102, Sjögren-Larsson Syndrome
Additional relevant MeSH terms:
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Sjogren's Syndrome
Sjogren-Larsson Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ichthyosis
Skin Abnormalities
Congenital Abnormalities
Lipidoses
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Skin Diseases, Genetic
Infant, Newborn, Diseases
Keratosis