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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: DCY636

Detailed Description

This is a two-part FIH, randomized, placebo-controlled, participant- and investigator-blinded study in healthy participants (Part 1) and participants with moderate to severe AD (Part 2).

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +81337978748; Email: novartis.email@novartis.com

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1- Cohort A1: Dose Level 1 DCY636; Cohort A1: Dose Level 1 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 1- Cohort A2: Dose Level 2 DCY636; Cohort A2: Dose Level 2 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 1- Cohort A3: Dose Level 3 DCY636; Cohort A3: Dose Level 3 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 1- Cohort A4: Dose Level 4 DCY636; Cohort A4: Dose Level 4 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 1- Cohort B1: Dose Level 5 DCY636; Cohort B1: Dose Level 5 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 1- Cohort B2: Dose Level 6 DCY636; Cohort B2: Dose Level 6 DCY636 in healthy participants.	Drug: DCY636; Participants will receive DCY636
Experimental: Part 2- Cohort C1: Dose Level 7 DCY636; Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis.	Drug: DCY636; Participants will receive DCY636
Placebo Comparator: Part 1- Cohort A1: Placebo; Cohort A1: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 1- Cohort A2: Placebo; Cohort A2: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 1- Cohort A3: Placebo; Cohort A3: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 1- Cohort A4: Placebo; Cohort A4: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 1- Cohort B1: Placebo; Cohort B1: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 1- Cohort B2: Placebo; Cohort B2: Placebo in healthy participants.	Drug: Placebo; Participants will receive Placebo
Placebo Comparator: Part 2- Cohort C1: Placebo; Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis.	Drug: Placebo; Participants will receive Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)	Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.	Up to approximately 202 days
Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)	Number of participants with adverse events (AEs) and serious adverse events (SAEs), including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.	Up to approximately 301 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636	Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.	up to Day 202
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636	AUC is the area under the plasma concentration-time curve.	up to Day 202
Part 1-Anti-drug antibodies against DCY636	To assess immunogenicity (IG) of DCY636.	up to Day 202
Part 2-Pharmacokinetic (PK) parameter: Cmax of DCY636	Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.	up to Day 301
Part 2-Pharmacokinetic (PK) parameter: AUC of DCY636	AUC is the area under the plasma concentration-time curve.	up to Day 301
Part 2-Anti-drug antibodies against DCY636	To assess immunogenicity (IG) of DCY636.	up to Day 301

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): January 27, 2028
• Study Completion (Estimated): January 28, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; PK; Phase 1; healthy volunteers; AD; safety and tolerability; FIH
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema
• Other Study ID Numbers: CDCY636A02101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No