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New eczema drug enters first human tests

NCT ID NCT07604324

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This early-stage study tests a new drug called DCY636 for safety and tolerability in healthy volunteers and people with moderate to severe atopic dermatitis (eczema). The trial has two parts: a single dose in healthy adults and multiple doses in eczema patients. It aims to gather initial safety data to support further development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DCY636
What this could lead to
If this early trial shows DCY636 is safe, it could pave the way for a new treatment option for people with moderate to severe atopic dermatitis.
What could go wrong
This is a very early Phase 1 study focused on safety, not effectiveness. The drug may not work or could have side effects. It will take years before any potential treatment is available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 812-0025, Japan

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