Evaluating a new treatment for moderate to severe atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a new treatment, referred to as 611, in combination with topical corticosteroids for patients suffering from moderate to severe atopic dermatitis. Participants will be randomly assigned to receive either the treatment or a placebo alongside standard corticosteroid therapy. The study aims to determine whether the addition of 611 can improve outcomes for patients who have not responded adequately to existing topical treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female adults ages 18 to 75 years old when signing the informed consent.
* AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
* Moderate to Severe Atopic Dermatitis.
* Recent history of inadequate response to treatment with topical medications.

Exclusion Criteria:

* Participation in a prior 611 clinical study.
* Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
* Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
* Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
* Evidence of active acute or chronic hepatitis.
* History of malignancy within 5 years before the screening visit or currently.
* Pregnant or breastfeeding women, or women planning to become pregnant.
* Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

Where it's running

• Shanghai Dermatology Hospital
  Shanghai, Shanghai, China Recruiting
• Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of Ningbo University
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Qinghong Zhou
• Email: zhouqinghong@3sbio.com
• Phone: +86 18911301578

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Camoteskimab in adults with moderate-to-severe atopic dermatitis

  This trial tests different doses of camoteskimab versus placebo to see if it helps adults with moderate-to-severe atopic dermatitis who have not fully responded to standard treatments.

  Recruiting at 31 sites Phase 2 Apollo Therapeutics Ltd · Birmingham, Alabama and 84 other locations · NCT07599813

• AR100DP1 cream for mild to moderate atopic dermatitis

  This study tests whether a 0.5% AR100DP1 topical treatment can help people with mild to moderate atopic dermatitis better than placebo over 14 days.

  Recruiting Phase 2 Arjil Pharmaceuticals LLC · Taipei, Taiwan and 1 other locations · NCT07914088

• 611 in Chinese children with moderate to severe atopic dermatitis

  A Phase 3 study tests whether 611 helps kids aged 2 to under 12 with moderate to severe atopic dermatitis compared with a placebo.

  Recruiting Phase 3 Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Beijing, Beijing Municipality and 4 other locations · NCT07767253

• First-in-human test of DCY636 in healthy adults and in people with moderate to severe atopic dermatitis

  This study will test whether DCY636 is safe and tolerated in healthy adults and whether it can be safely given to people with moderate to severe atopic dermatitis.

  Recruiting Phase 1 Novartis · Fukuoka · NCT07604324

• Soquelitinib for adults with moderate to severe atopic dermatitis

  This 12-week test gives adults with moderate to severe atopic dermatitis daily soquelitinib or a placebo to see if their skin and itch improve and to track side effects.

  Recruiting Phase 2 Corvus Pharmaceuticals, Inc. · South San Francisco, California · NCT07441395

• A medicine for eczema: see if PF-08049820 helps adults with moderate to severe atopic dermatitis

  This study tests whether PF-08049820, taken as a daily pill, can safely help adults with moderate to severe eczema compared to a placebo.

  Recruiting at 41 sites Phase 2 Pfizer · Phoenix, Arizona and 51 other locations · NCT07216027

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.