First-in-human test of DCY636 in healthy adults and in people with moderate to severe atopic dermatitis
Official title: 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
Run by Novartis · NCT07604324 · Data updated 2026-11-12
This study will test whether DCY636 is safe and tolerated in healthy adults and whether it can be safely given to people with moderate to severe atopic dermatitis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 63 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (Fukuoka) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | January 27, 2028 |
| Study ends | January 28, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07604324 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants include healthy adults aged 18–55 for Part 1, and adults aged 18 or older with moderate to severe atopic dermatitis who have not responded adequately to topical therapy for Part 2.
✕Probably not a fit
Patients with atopic dermatitis who do not show a favorable safety or PK/PD profile or who have contraindications to study procedures may not benefit.
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 two-part first-in-human study that randomizes participants to DCY636 or placebo in a blinded fashion. Part 1 enrolls healthy adults to evaluate safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics. Part 2 enrolls adults with moderate to severe atopic dermatitis to assess safety and PK/PD in the target patient population. The trial is placebo-controlled and investigator-blinded, with single-dose administration in healthy participants and multiple-dose administration in patients. The results will support further clinical development of DCY636 for dermatitis if safety and PK/PD profiles are favorable.
Why it matters
Potential benefit: If successful, DCY636 could become a new treatment approach for atopic dermatitis by demonstrating acceptable safety and meaningful pharmacodynamic effects.
How similar studies have gone: Previous early-phase studies in similar biologic/therapeutic classes have shown that careful dose-ranging and blinding can establish safety and PK/PD signals, though this exact agent is first-in-human.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: Healthy Participants (Part 1) • Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive. Participants with moderate to severe atopic dermatitis (Part 2) * Males and non-pregnant females age 18 years or older * Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals * Moderate to severe atopic dermatitis as defined by all of the following: * EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit * IGA score ≥3 at screening visit and baseline visit * Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit * Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit Key Exclusion Criteria: All Participants (Part 1, Part 2) * Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer. * Meet any of the prohibited medication use criteria at baseline visit. * A positive syphilis test result during screening period. * Evidence of active or latent TB infection, as determined by T-Spot test during screening period. * History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result. * Recent (within last half year) or ongoing helminth infection. * History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and/or Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded. Healthy Participants (Part 1) * Women of childbearing potential * Smokers Participants with moderate to severe atopic dermatitis (Part 2) * Regular use (more than 2 visits per week) of a tanning booth/parlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit * Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment * Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment. Other protocol-defined inclusion/exclusion criteria may apply.
Where it's running
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Novartis Investigative Site
Fukuoka, Japan Recruiting
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +81337978748
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.