SYX-5219 in healthy adults and adults with moderate-to-severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, multi-part, double-blind Phase 1 program that measures safety, tolerability, and pharmacokinetics of oral SYX-5219. Part 1 includes single ascending doses and a food-effect evaluation in healthy volunteers; Part 2 includes multiple ascending doses in healthy volunteers. Part 3 enrolls adults with moderate-to-severe atopic dermatitis who will be randomized to SYX-5219 or placebo for up to 42 days to collect safety and exploratory efficacy data. Early parts are done at a single site and the later part is run across multiple global sites with standard safety and PK sampling throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Parts 1 \& 2

* Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg/m2.
* Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.
* No clinically significant abnormalities in laboratory, vital signs or ECG measurements.

Part 3

* Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg/m2.
* Meet minimum AD entry criteria;

  * AD covering ≥10% of the body surface area (BSA) at screening and baseline.
  * Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
  * Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.
  * Peak Pruritus NRS score of ≥ 4 at screening and baseline.

Exclusion Criteria:

Parts 1 \& 2

• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.

Part 3

* Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk.
* Has medical history as stated in the main study exclusion criteria.
* Received treatment(s) as stated in the main study exclusion criteria.

Where it's running

• Sitryx Clinical Site
  Arkansas City, Arkansas, United States Recruiting
• Sitryx Clinical Site
  Fremont, California, United States Recruiting
• Sitryx Clinical Site
  Plainfield, Indiana, United States Recruiting
• Sitryx Clinical Site
  Boardman, Ohio, United States Recruiting
• Sitryx Clinical Site
  Philadelphia, Pennsylvania, United States Recruiting
• Sitryx Clinical Site
  Bountiful, Utah, United States Recruiting

Study contacts

• Study coordinator: Sitryx Therapeutics
• Email: info@sitryx.com
• Phone: +44 (0)1865 648401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A Phase 3 test of Rezpegaldesleukin (NKTR-358) for moderate-to-severe atopic dermatitis in patients 12 years and older

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• Rezpegaldesleukin for moderate-to-severe atopic dermatitis in people 12 and older

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• Nemolizumab for infants with moderate-to-severe atopic dermatitis

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• TRB-061 injections for healthy adults and people with moderate-to-severe atopic dermatitis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.