臨床研究等提出・公開システム

Date of registration	May. 26, 2026
Last modified on	May. 26, 2026
Trial ID	jRCT2071260032

Scientific 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 (CDCY636A02101)
Public 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 (CDCY636A02101)

Contact for Scientific Queries	Name	Sato Mika
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com
Contact for Public Queries	Name	Sato Mika
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku@novartis.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 02, 2026
Target sample size		63
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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 - GA 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
	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.
	Age Minimum	18age old over
	Age Maximum	100age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		atopic dermatitis
Intervention(s)		DCY636 Part 1- CohortA1: Dose Level 1 DCY636 Part 1- CohortA2: Dose Level 2 DCY636 Part 1- CohortA3: Dose Level 3 DCY636 Part 1- CohortA4: Dose Level 4 DCY636 Part 1- CohortB1: Dose Level 5 DCY636 Part 1- CohortB2: Dose Level 6 DCY636 Part 2- CohortC1: Dose Level 7 DCY636 Placebo Part 1- CohortA1: Placebo Part 1- CohortA2: Placebo Part 1- CohortA3: Placebo Part 1- CohortA4: Placebo Part 1- CohortB1: Placebo Part 1- CohortB2: Placebo Part 2- CohortC1: Placebo
Primary Outcome(s)		Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs) Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)

Primary Sponsor	Novartis Pharma. K.K.

Secondary Sponsor

Name of Certified Review Board	SOUSEIKAI Hakata Clinic Institutional Review Board
Address	6-18 Tenyamachi, Hakata-ku, Fukuoka, Fukuoka
Approval Status	Approval
Date of approval	April. 16, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07604324
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	none