PRA-216 for moderate to severe atopic dermatitis: safety and how it works in the body

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 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of PRA-216 in adults with moderate to severe atopic dermatitis who have not adequately responded to topical corticosteroids. Participants are randomized in a 2:1 ratio to receive PRA-216 or placebo via subcutaneous injections four times during the study. The trial will monitor adverse events, efficacy signals, and how the drug behaves in the body across the treatment period. The study aims to determine whether PRA-216 can be safely combined with standard care and potentially improve disease control in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Must be in good health with no significant medical history
* Willing and able to attend all study visits, comply with study requirements.
* Able and willing to provide written informed consent
* Documented AD diagnosis prior to enrollment.
* History of inadequate response to topical medications for AD

Exclusion Criteria:

* Evidence of clinically significant skin condition or disease other than AD
* Any physical or psychological condition that prohibits study completion
* Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent
* History of severe allergic reactions or hypersensitivity
* Receipt of antibody therapy within 4 months or 5 half-lives
* Other investigational agent(s) within 30 days or 5 half-lives

Where it's running

• Emeritus Sydney
  Botany, New South Wales, Australia Recruiting
• Cornerstone Centre for Clinical Research
  Coorparoo, Queensland, Australia Recruiting
• Optimal Clinical Trials (North)
  Auckland, New Zealand Recruiting
• Aotearoa Clinical Trials
  Auckland, New Zealand Recruiting
• Momentum Christchurch
  Christchurch, New Zealand Recruiting
• Clinical Trials New Zealand
  Hamilton, New Zealand Recruiting

Similar studies

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

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• Skin structure in atopic dermatitis patients treated with nemolizumab assessed by reflectance confocal microscopy

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  Recruiting Hôpitaux Drôme Nord · Romans-sur-Isère, Drôme · NCT07730788

• Global Health Look at Atopic Dermatitis

  A worldwide, multicenter study tests how people with atopic dermatitis access care and treat it, using data from routine medical records.

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• Stapokibart Injection for atopic dermatitis in adults

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• S-4321 in adults with autoimmune or immune-mediated diseases

  This study tests S-4321 in adults with autoimmune conditions to see if it is safe and tolerable and to gather early data on how the drug behaves in the body and its initial effects on disease markers.

  Recruiting at 2 sites Phase 1 Seismic Therapeutic AU Pty Ltd · Charlestown, New South Wales and 1 other locations · NCT07455578

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.