A Phase 2 interventional study of Active PRA-216 and Placebo in Atopic Dermatitis (AD), sponsored by Prana Therapies Inc. Recruiting at 9 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Prana Therapies Inc · Phase 2, Interventional, and Treatment
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 a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy response of PRA-216 in patients with moderate to severe Atopic Dermatitis (AD). Eligible participants will be those with AD who are inadequately controlled by topical corticosteroids (TCS) or had adverse reaction or contraindication to the medication.
This study will enroll approximately 39 participants at multiple study sites who will be randomized 2:1 to receive either PRA-216 or placebo subcutaneous injections four times throughout the study period.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 39 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Prana Therapies Inc is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 28, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with moderate to severe AD will be randomized to receive PRA-216
Drug: Active PRA-216
Participants with moderate to severe AD will be randomized to receive placebo
Drug: Placebo
biologic
matching placebo for PRA-216
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe atopic dermatitis (AD)
Time frame: Up to 28 weeks
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD
Mean percent change from baseline in Eczema Area and Severity Index (EASI). EASI is a score that will grade atopic dermatitis, with a higher number indicating more severe disease. A score of 0 indicates clear skin, and a score of 72 is severe disease.
Time frame: Up to 24 weeks
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75
Percentage of patients achieving EASI-75. EASI-75 indicates a 75% improvement in severity and spread of skin lesions compared to baseline.
Time frame: Up to 24 weeks
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90
Percentage of patients achieving EASI-90. EASI-90 indicates a 90% improvement in severity and spread of skin lesions compared to baseline.
Time frame: Up to 24 weeks
Pharmacokinetics of PRA-216: Tmax in patients with AD
Time to maximum concentration of drug in plasma
Time frame: Up to 28 weeks
Pharmacokinetics of PRA-216: AUC in patients with AD
Area under the curve
Time frame: Up to 28 weeks
Pharmacokinetics of PRA-216: Cmax in patients with AD
Maximum concentration of PRA-216 in plasma
Time frame: Up to 28 weeks
Immunogenicity of PRA-216: ADA in patients with AD
Incidence of anti-drug antibody following drug administration
Time frame: Up to 24 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prana Therapies Inc