Moderate to Severe Atopic Dermatitis study: SYX-5219 Oral Capsule
Official title A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
ClinicalTrials.gov ID: NCT07558668
What this study is testing
What is SYX-5219 Oral Capsule?
SYX-5219 Oral Capsule is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for moderate to severe atopic dermatitis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether SYX‑5219 is safe and well‑tolerated and to measure how the drug appears in blood and urine.
- Who it's for
- Adults with moderate to severe atopic dermatitis (and healthy adult volunteers) are eligible.
- What's involved
- Participants will receive a daily dose of SYX‑5219 or a placebo for up to 42 days, with clinic visits for blood and urine tests and other safety checks; early parts involve single or multiple dose testing in healthy volunteers.
- Time commitment
- The trial lasts about 6 weeks, with regular clinic visits for dosing and sample collection.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put...
- Has medical history as stated in the main study exclusion criteria.
- Received treatment(s) as stated in the main study exclusion criteria.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Arkansas City, Arkansas, United States
- Fremont, California, United States
- Plainfield, Indiana, United States
- Boardman, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Bountiful, Utah, United States
- Sofia, Bulgaria
- Berlin, Germany
- Frankfurt, Germany
- Dublin, Ireland
- Manchester, United Kingdom
- Merthyr Tydfil, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Arkansas City, Arkansas, United States; Fremont, California, United States; Plainfield, Indiana, United States; Boardman, Ohio, United States; Philadelphia, Pennsylvania, United States; Bountiful, Utah, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.