Atopic Dermatitis (AD)Phase 2NCT07810777
PRA-216 Atopic Dermatitis Safety and Efficacy Study
A Phase 2 study testing Active PRA-216 in people with Atopic Dermatitis (AD), run by Prana Therapies Inc at 8 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Active PRA-216
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Sep 2026to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Australia4 sites
Emeritus Sydney
Botany, New South Wales, 2019
Priya Loomba, MD, 02 8964 8186, priyaloomba@emeritusresearch.com
Priya Loomba, MD
Emeritus Melbourne
Camberwell, Victoria, 3124
Raf Malik, MD, 03 9509 6166, rafikmalik@emeritusresearch.com
Raf Malik, MD
Cornerstone Centre for Clinical Research
Coorparoo, Queensland, 4151
Young Jin Kim, MD, +61 7 2102 5054, drkim@cornerstonederm.com.au
Young Jin Kim, MD
Momentum Sunshine
Melbourne, Victoria, 3021
King Cheung, MD, 03 9125 0799, King.Cheung@momentumclinicalresearch.com.au
King Cheung, MD
New Zealand4 sites
Optimal Clinical Trials (North)
Auckland, 0627
Claudette Lionnet, MD, +64 9 303 4987, Claudette@optimalclinicaltrials.com
Claudette Lionnet, MD
Aotearoa Clinical Trials
Auckland, 2025
Cheng Huang, MD, +64 9 276 0000, cheng.huang@TeWhatuOra.govt.nz
Cheng Huang, MD
Momentum Christchurch
Christchurch, 8013
Ben Image, MD, 64 3 337 1976, benimage@pcrn.co.nz
Ben Image, MD
Clinical Trials New Zealand
Hamilton, 3204
Amy Stanway, MD, +64 7 843 0105, amystanway@yahoo.co.nz
Amy Stanway, MD
About this study
Official title: 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
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)
Read the detailed description
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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Active PRA-216, Placebo
- Keywords
- Inflammatory response, pharmacokinetics, pharmacodynamics, immunogenicity
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PRA-216Drug
biologic
PlaceboDrug
matching placebo for PRA-216
| Study group | Role | What they receive |
|---|---|---|
| Active PRA-216 | Active comparator | Participants with moderate to severe AD will be randomized to receive PRA-216 Receives: Drug: Active PRA-216 |
| Placebo | Placebo comparator | Participants with moderate to severe AD will be randomized to receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 28 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: Up to 24 weeks
Pharmacokinetics of PRA-216: Tmax in patients with AD
Time to maximum concentration of drug in plasma
Measured: Up to 28 weeks
Pharmacokinetics of PRA-216: AUC in patients with AD
Area under the curve
Measured: Up to 28 weeks
Pharmacokinetics of PRA-216: Cmax in patients with AD
Maximum concentration of PRA-216 in plasma
Measured: Up to 28 weeks
Immunogenicity of PRA-216: ADA in patients with AD
Incidence of anti-drug antibody following drug administration
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prana Therapies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810777
- Sponsor's protocol ID
- PRA-216-301
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07810777
- Acronym / sponsor ID
- PRA-216-301
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- Inflammatory response, pharmacokinetics, pharmacodynamics, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Prana Therapies IncIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PRA-216 | Active comparator | Drug: Active PRA-216Participants with moderate to severe AD will be randomized to receive PRA-216 |
| Placebo | Placebo comparator | Drug: PlaceboParticipants with moderate to severe AD will be randomized to receive placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active PRA-216biologic | Drug | Active PRA-216 |
| Placebomatching placebo for PRA-216 | Drug | Placebo |
Primary outcome
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 28 weeks
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)
7 secondary outcomes
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD
Time frame: Up to 24 weeks
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-75
Time frame: Up to 24 weeks
Clinical efficacy of PRA-216 compared to placebo in participants with moderate to severe AD: EASI-90
Time frame: Up to 24 weeks
Pharmacokinetics of PRA-216: Tmax in patients with AD
Time frame: Up to 28 weeks
Pharmacokinetics of PRA-216: AUC in patients with AD
Time frame: Up to 28 weeks
Pharmacokinetics of PRA-216: Cmax in patients with AD
Time frame: Up to 28 weeks
Immunogenicity of PRA-216: ADA in patients with AD
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cornerstone Centre for Clinical Research
Coorparoo, Australia
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active PRA-216 in people with Atopic Dermatitis (AD), run by Prana Therapies Inc at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.