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DCY636

Phase 1

Dermatitis, Atopic | Small molecule | Dermatology |Novartis AG|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

DCY636 · 1 trial · 1 indication

Phase 1 1
NCT07604324A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic DermatitisDermatitis, Atopic
RECRUITING63 Analytics
PHASE1RECRUITING
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
Dermatitis, AtopicUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Up to approximately 202 days

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.

Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Up to approximately 301 days

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.

Secondary Endpoints

Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636
up to Day 202
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636
up to Day 202
Part 1-Anti-drug antibodies against DCY636
up to Day 202
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1- Cohort A1: Dose Level 1 DCY636EXPERIMENTALCohort A1: Dose Level 1 DCY636 in healthy participants.
Part 1- Cohort A2: Dose Level 2 DCY636EXPERIMENTALCohort A2: Dose Level 2 DCY636 in healthy participants.
Part 1- Cohort A3: Dose Level 3 DCY636EXPERIMENTALCohort A3: Dose Level 3 DCY636 in healthy participants.
Part 1- Cohort A4: Dose Level 4 DCY636EXPERIMENTALCohort A4: Dose Level 4 DCY636 in healthy participants.
Part 1- Cohort B1: Dose Level 5 DCY636EXPERIMENTALCohort B1: Dose Level 5 DCY636 in healthy participants.
Part 1- Cohort B2: Dose Level 6 DCY636EXPERIMENTALCohort B2: Dose Level 6 DCY636 in healthy participants.
Part 2- Cohort C1: Dose Level 7 DCY636EXPERIMENTALPart 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis.
Part 1- Cohort A1: PlaceboPLACEBO_COMPARATORCohort A1: Placebo in healthy participants.
Part 1- Cohort A2: PlaceboPLACEBO_COMPARATORCohort A2: Placebo in healthy participants.
Part 1- Cohort A3: PlaceboPLACEBO_COMPARATORCohort A3: Placebo in healthy participants.
Part 1- Cohort A4: PlaceboPLACEBO_COMPARATORCohort A4: Placebo in healthy participants.
Part 1- Cohort B1: PlaceboPLACEBO_COMPARATORCohort B1: Placebo in healthy participants.
Part 1- Cohort B2: PlaceboPLACEBO_COMPARATORCohort B2: Placebo in healthy participants.
Part 2- Cohort C1: PlaceboPLACEBO_COMPARATORPart 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis.

Interventions

NameTypeDescription
DCY636DRUGParticipants will receive DCY636
PlaceboDRUGParticipants will receive Placebo
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 de...

Countries:Japan
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07604324lastUpdatePostDate: changed
LOWAug 20, 2026NCT07604324lastUpdatePostDate: changed
LOWAug 20, 2026NCT07604324lastUpdatePostDate: changed
LOWAug 20, 2026NCT07604324lastUpdatePostDate: changed
LOWJul 20, 2026NCT07604324lastUpdatePostDate: changed
LOWJul 20, 2026NCT07604324lastUpdatePostDate: changed
LOWJun 16, 2026NCT07604324lastUpdatePostDate: changed
LOWJun 16, 2026NCT07604324lastUpdatePostDate: changed
LOWJun 16, 2026NCT07604324lastUpdatePostDate: changed

Frequently asked questions about DCY636

What is DCY636 used for?

DCY636 is an investigational small molecule being developed for the treatment of moderate to severe atopic dermatitis, a form of eczema. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing DCY636?

DCY636 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is DCY636 in?

DCY636 is currently in Phase 1 clinical development. It is being studied in a first-in-human trial that includes healthy volunteers and participants with moderate to severe atopic dermatitis. The drug is investigational and has not yet received regulatory approval.

What clinical trials is DCY636 in?

DCY636 is being evaluated in a Phase 1 clinical trial registered as NCT07604324. This first-in-human study is investigating single doses of DCY636 in healthy volunteers and multiple doses in participants with moderate to severe atopic dermatitis. The trial is currently recruiting participants in Japan.

Is DCY636 being studied in a randomized controlled trial?

Yes, the Phase 1 clinical trial of DCY636 is a randomized, double-blind, placebo-controlled study. This design helps researchers compare the effects of the drug against a placebo to assess its safety and tolerability in both healthy volunteers and patients with atopic dermatitis.