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

A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).

This trial will test oral SYX-5219 in healthy adults and in adults with moderate-to-severe atopic dermatitis to see if it is safe, well tolerated, and how the drug is processed in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 149 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sitryx Therapeutics Ltd (Industry-sponsored)
• Locations: 14 sites (Arkansas City, Arkansas and 13 other locations)
• Trial ID: NCT07558668 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with a confirmed diagnosis of moderate-to-severe atopic dermatitis meeting entry thresholds (≥10% BSA, EASI ≥16, vIGA ≥3, peak pruritus ≥4) and who meet the study's other health and medication restrictions.

Not a fit: Children, people with mild atopic dermatitis, those with major uncontrolled medical conditions, pregnant people, or those unable to stop prohibited systemic therapies are unlikely to be eligible or benefit from this Phase 1 program.

Why it matters

Potential benefit: If successful, SYX-5219 could become a new oral treatment option that reduces symptoms for people with moderate-to-severe atopic dermatitis.

How similar studies have performed: This is a first-in-human program for SYX-5219; while some other oral small-molecule drugs for atopic dermatitis have shown benefit in later trials, this specific compound has not yet been tested in humans.

Eligibility criteria

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 this trial is running

Arkansas City, Arkansas and 13 other locations

• 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)
• Sitryx Clinical Site — Sofia, Bulgaria (Recruiting)
• Sitryx Clinical Site — Herlev, Herlev, Denmark (Not_yet_recruiting)
• Sitryx Clinical Site — Berlin, Germany (Recruiting)
• Sitryx Clinical Site — Frankfurt, Germany (Recruiting)
• Sitryx Clinical Site — Freiburg im Breisgau, Germany (Active_not_recruiting)
• Sitryx Clinical Site — Dublin, Ireland (Recruiting)
• Sitryx Clinical Site — Manchester, United Kingdom (Recruiting)
• Sitryx Clinical Site — Merthyr Tydfil, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Sitryx Therapeutics

Conditions Moderate to Severe Atopic Dermatitis