Dermatitis, AtopicPhase 1NCT07604324
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 Phase 1 study testing DCY636 in people with Dermatitis, Atopic, run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- DCY636
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteJapan
- Study dates
- 2 Jun 2026to 28 Jan 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Japan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Fukuoka, 812-0025
About this study
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
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.
Read the 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).
- Conditions
- Dermatitis, Atopic
- Being tested
- DCY636, Placebo
- Keywords
- Phase 1, FIH, safety and tolerability, healthy volunteers, PK, atopic dermatitis, AD, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCY636Drug
Participants will receive DCY636
PlaceboDrug
Participants will receive Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1- Cohort A1: Dose Level 1 DCY636 | Experimental | Cohort A1: Dose Level 1 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 1- Cohort A2: Dose Level 2 DCY636 | Experimental | Cohort A2: Dose Level 2 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 1- Cohort A3: Dose Level 3 DCY636 | Experimental | Cohort A3: Dose Level 3 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 1- Cohort A4: Dose Level 4 DCY636 | Experimental | Cohort A4: Dose Level 4 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 1- Cohort B1: Dose Level 5 DCY636 | Experimental | Cohort B1: Dose Level 5 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 1- Cohort B2: Dose Level 6 DCY636 | Experimental | Cohort B2: Dose Level 6 DCY636 in healthy participants. Receives: Drug: DCY636 |
| Part 2- Cohort C1: Dose Level 7 DCY636 | Experimental | Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis. Receives: Drug: DCY636 |
| Part 1- Cohort A1: Placebo | Placebo comparator | Cohort A1: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 1- Cohort A2: Placebo | Placebo comparator | Cohort A2: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 1- Cohort A3: Placebo | Placebo comparator | Cohort A3: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 1- Cohort A4: Placebo | Placebo comparator | Cohort A4: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 1- Cohort B1: Placebo | Placebo comparator | Cohort B1: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 1- Cohort B2: Placebo | Placebo comparator | Cohort B2: Placebo in healthy participants. Receives: Drug: Placebo |
| Part 2- Cohort C1: Placebo | Placebo comparator | Part 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 301 days
Secondary outcomes (6)
Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636
Cmax is the maximum (peak) observed blood concentration of DCY636 after dose administration.
Measured: up to Day 202
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636
AUC is the area under the plasma concentration-time curve.
Measured: up to Day 202
Part 1-Anti-drug antibodies against DCY636
To assess immunogenicity (IG) of DCY636.
Measured: 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.
Measured: up to Day 301
Part 2-Pharmacokinetic (PK) parameter: AUC of DCY636
AUC is the area under the plasma concentration-time curve.
Measured: up to Day 301
Part 2-Anti-drug antibodies against DCY636
To assess immunogenicity (IG) of DCY636.
Measured: up to Day 301
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start2 Jun 2026
- Primary completion27 Jan 2028 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604324
- Sponsor's protocol ID
- CDCY636A02101
- Status last verified
- Aug 2026
- First submitted
- 18 May 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07604324
- Acronym / sponsor ID
- CDCY636A02101
- Conditions
- Dermatitis, Atopic
- Keywords
- Phase 1, FIH, safety and tolerability, healthy volunteers, PK, atopic dermatitis, AD, eczema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 27 Jan 2028 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1- Cohort A1: Dose Level 1 DCY636 | Experimental | Drug: DCY636Cohort A1: Dose Level 1 DCY636 in healthy participants. |
| Part 1- Cohort A2: Dose Level 2 DCY636 | Experimental | Drug: DCY636Cohort A2: Dose Level 2 DCY636 in healthy participants. |
| Part 1- Cohort A3: Dose Level 3 DCY636 | Experimental | Drug: DCY636Cohort A3: Dose Level 3 DCY636 in healthy participants. |
| Part 1- Cohort A4: Dose Level 4 DCY636 | Experimental | Drug: DCY636Cohort A4: Dose Level 4 DCY636 in healthy participants. |
| Part 1- Cohort B1: Dose Level 5 DCY636 | Experimental | Drug: DCY636Cohort B1: Dose Level 5 DCY636 in healthy participants. |
| Part 1- Cohort B2: Dose Level 6 DCY636 | Experimental | Drug: DCY636Cohort B2: Dose Level 6 DCY636 in healthy participants. |
| Part 2- Cohort C1: Dose Level 7 DCY636 | Experimental | Drug: DCY636Part 2- Cohort C1: Dose Level 7 DCY636 in participants with moderate to severe atopic dermatitis. |
| Part 1- Cohort A1: Placebo | Placebo comparator | Drug: PlaceboCohort A1: Placebo in healthy participants. |
| Part 1- Cohort A2: Placebo | Placebo comparator | Drug: PlaceboCohort A2: Placebo in healthy participants. |
| Part 1- Cohort A3: Placebo | Placebo comparator | Drug: PlaceboCohort A3: Placebo in healthy participants. |
| Part 1- Cohort A4: Placebo | Placebo comparator | Drug: PlaceboCohort A4: Placebo in healthy participants. |
| Part 1- Cohort B1: Placebo | Placebo comparator | Drug: PlaceboCohort B1: Placebo in healthy participants. |
| Part 1- Cohort B2: Placebo | Placebo comparator | Drug: PlaceboCohort B2: Placebo in healthy participants. |
| Part 2- Cohort C1: Placebo | Placebo comparator | Drug: PlaceboPart 2- Cohort C1: Placebo in participants with moderate to severe atopic dermatitis. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCY636Participants will receive DCY636 | Drug | Part 1- Cohort A1: Dose Level 1 DCY636, Part 1- Cohort A2: Dose Level 2 DCY636, Part 1- Cohort A3: Dose Level 3 DCY636, Part 1- Cohort A4: Dose Level 4 DCY636, Part 1- Cohort B1: Dose Level 5 DCY636, Part 1- Cohort B2: Dose Level 6 DCY636, Part 2- Cohort C1: Dose Level 7 DCY636 |
| PlaceboParticipants will receive Placebo | Drug | Part 1- Cohort A1: Placebo, Part 1- Cohort A2: Placebo, Part 1- Cohort A3: Placebo, Part 1- Cohort A4: Placebo, Part 1- Cohort B1: Placebo, Part 1- Cohort B2: Placebo, Part 2- Cohort C1: Placebo |
Primary outcome
Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Part 1-Pharmacokinetic (PK) parameter: Cmax of DCY636
Time frame: up to Day 202
Part 1-Pharmacokinetic (PK) parameter: AUC of DCY636
Time frame: up to Day 202
Part 1-Anti-drug antibodies against DCY636
Time frame: up to Day 202
Part 2-Pharmacokinetic (PK) parameter: Cmax of DCY636
Time frame: up to Day 301
Part 2-Pharmacokinetic (PK) parameter: AUC of DCY636
Time frame: up to Day 301
Part 2-Anti-drug antibodies against DCY636
Time frame: up to Day 301
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DCY636 in people with Dermatitis, Atopic, run by Novartis Pharmaceuticals at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+81337978748, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to approximately 202 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.