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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 39 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Atopic dermatitis (AD) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

    8 sites in 2 countries. 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

  • Aotearoa Clinical Trials

    Auckland, 2025, New Zealand

  • Clinical Trials New Zealand

    Hamilton, 3204, New Zealand

  • Cornerstone Centre for Clinical Research

    Coorparoo, Queensland, 4151, Australia

  • Emeritus Melbourne

    Camberwell, Victoria, 3124, Australia

  • Emeritus Sydney

    Botany, New South Wales, 2019, Australia

  • Momentum Christchurch

    Christchurch, 8013, New Zealand

  • Momentum Sunshine

    Melbourne, Victoria, 3021, Australia

  • Optimal Clinical Trials (North)

    Auckland, 0627, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.