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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1

Age range

18 years - 55 years

Sex eligible

All sexes

Healthy volunteers

Accepted

Participants

63 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Double masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Novartis Pharmaceuticals

Study start

Jun 2, 2026 Actual

Primary completion

Jan 27, 2028 Estimated

Study completion

Jan 28, 2028 Estimated

First posted

May 22, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts