A phase 2 randomized, double-blind, Placebo-Controlled, Parallel-Group, Multi-Center study to evaluate the safety and efficacy of PRA-216 in participants with moderate to severe atopic dermatitis
NCT ID NCT07810777
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 for at least 6 months 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
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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.
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The places running it
8 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Aotearoa Clinical Trials
Auckland, 2025, New Zealand
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Clinical Trials New Zealand
Hamilton, 3204, New Zealand
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Cornerstone Centre for Clinical Research
Coorparoo, Queensland, 4151, Australia
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Emeritus Melbourne
Camberwell, Victoria, 3124, Australia
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Emeritus Sydney
Botany, New South Wales, 2019, Australia
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Momentum Christchurch
Christchurch, 8013, New Zealand
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Momentum Sunshine
Melbourne, Victoria, 3021, Australia
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Optimal Clinical Trials (North)
Auckland, 0627, New Zealand
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