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New treatment option for Dermatitis, Atopic
Official 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
ClinicalTrials.gov ID: NCT07604324
What this study is testing
What is DCY636?
DCY636 is an investigational medicine, being studied as a potential treatment for dermatitis, atopic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Key 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...
- 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:
You likely can't join if
- 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.
See the full eligibility criteria
- Key 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
- 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)...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.