Actively Recruiting
A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis
Led by Novartis Pharmaceuticals · Updated on 2026-05-29
63
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of the drug DCY636. The study includes both healthy volunteers and participants with moderate to severe atopic dermatitis (AD), aiming to support further clinical development of DCY636. This randomized, placebo-controlled, double-blind study is divided into two parts to carefully assess different participant groups. The study involves multiple dose levels of DCY636 administered to healthy participants in Part 1 and to participants with moderate to severe AD in Part 2. Participants are randomly assigned to receive either DCY636 or a placebo, with dose escalation in healthy volunteers followed by multiple dosing in AD participants. The trial monitors responses across several cohorts with varying doses to understand the drug's behavior and effects. Participants will undergo regular monitoring for adverse events and serious adverse events over approximately 202 days for healthy volunteers and 301 days for those with AD. Assessments include pharmacokinetic parameters like maximum concentration and area under the curve of DCY636, as well as testing for anti-drug antibodies. The study tracks safety, drug effects, and immune responses throughout the trial duration to inform future research and development.
CONDITIONS
Brief Title
A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and non-childbearing potential female participants aged 18 to 55 years for Part 1
- Males and non-pregnant females aged 18 years or older with moderate to severe atopic dermatitis for Part 2
- Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topical treatments
- Moderate to severe atopic dermatitis defined by EASI score ≥12 at screening and ≥16 at baseline
- IGA score ≥3 at screening and baseline
- Total body surface area affected by atopic dermatitis ≥10% at screening and baseline
- Peak Pruritus Numeric Rating Scale score ≥4 at baseline based on weekly average of daily assessments prior to baseline
You will not qualify if you...
- Use of other investigational drugs within 30 days or 5 half-lives prior to dosing
- Prohibited medication use at baseline visit
- Positive syphilis test during screening
- Evidence of active or latent tuberculosis infection
- History of immunodeficiency diseases or positive HIV test
- Recent or ongoing helminth infection within last 6 months
- History or serologic evidence of hepatitis B or C infection
- Women of childbearing potential (Part 1) and those not using effective contraception (Part 2)
- Smokers (Part 1)
- Regular use of tanning booths or extended sun exposure within 4 weeks prior to baseline (Part 2)
- Chronic uncontrolled medical conditions that increase risk during study participation
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 202 days for healthy participants and up to approximately 301 days for participants with moderate to severe atopic dermatitis
Participants receive either DCY636 or placebo as part of the study intervention.
Visits scheduled throughout the treatment period depending on cohort assignment
Duration - Up to approximately 202 days for healthy participants and up to approximately 301 days for participants with moderate to severe atopic dermatitis
Participants are monitored for safety, tolerability, and pharmacokinetics after treatment.
Visits scheduled to assess adverse events and pharmacokinetics during follow-up
Trial Site Locations
Total: 1 location
1
Novartis Investigative Site
Fukuoka, Japan, 812-0025
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
14
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