A clinical study to evaluate the safety and effect of PRA-523, an investigational drug, compared to a drug with no active ingredient for the treatment of itch caused by atopic dermatitis
| ISRCTN | ISRCTN63487177 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63487177 |
| Sponsor | Praeventix, Inc. |
| Funder | Praeventix, Inc. |
- Submission date
- 15/01/2026
- Registration date
- 21/01/2026
- Last edited
- 13/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The study aims to evaluate whether PRA-523 is safe, how it is metabolized by the body, and whether it improves itch symptoms due to atopic dermatitis as compared to placebo.
Who can participate?
Adults 18-69 years with itchy skin from atopic dermatitis/eczema may participate in this study.
What does the study involve?
The study involves attending up to 9 in person visits to the clinical center over the course of approximately 11 weeks. Participants in the first phase of the study will be required to stay overnight in the clinic twice during the study.
All study participants will be required to complete a daily tracking diary of itch symptoms and study drug usage and will self-administer a topical cream at home for 28 days. This study is placebo-controlled, meaning that some participants will receive the study drug, and some will receive a look-alike drug that will not contain the active ingredient. You and your study doctor will not know which you have received.
What are the possible benefits and risks of participating?
Participants assigned to active treatment may experience relief of their pruritus symptoms during the study, but this is not guaranteed. In addition, participation will help researchers better understand the potential improvement of atopic dermatitis symptoms caused by the drug being studied and its overall safety. Risks associated with participation include those associated with study evaluations such as blood draws and ECGs. Risks associated with the study drug include local skin reactions at the application site.
Where is the study run from?
The study is being run at three clinical centers in New Zealand in Auckland (2) and Christchurch (1) .
When is the study starting and how long is it expected to run for?
February 2026 to March 2027
Who is funding the study?
The study is being funded by Praeventix, Inc., a biopharmaceutical company who is developing PRA-523.
Who is the main contact?
cohara@praeventix.com
Contact information
Public
665 Stockton Drive, Suite 200H
Exton
19341
United States of America
| cohara@praeventix.com |
Scientific
665 Stockton Drive, Suite 200H
Exton
19341
United States of America
| mmahowald@praeventix.com |
Principal investigator
Optimal Clinical Trials
Level 2, 97 Grafton Road
Grafton, Auckland
1010
New Zealand
| Phone | +64 800 73 73 27 |
|---|---|
| olu@optimalclinicaltrials.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind, randomized, adaptive, vehicle controlled first-in-human phase 1-2a trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A double-blind, randomized, adaptive, vehicle controlled first in-human phase 1-2a trial to determine the safety, pharmacokinetics, and efficacy of PRA-523 against pruritus secondary to atopic dermatitis |
| Study objectives | The study aims to determine PRA-523's safety, tolerability, pharmacokinetic profile and efficacy as compared to placebo |
| Ethics approval(s) |
Approved 22/12/2025, Central Health and Disability Ethics Committees (PO Box 5013, Wellington, 6140, New Zealand; +64 800 400 569; hdecs@health.govt.nz), ref: 2025 FULL 24409 |
| Health condition(s) or problem(s) studied | Pruritus secondary to atopic dermatitis |
| Intervention | Participants will be randomized to the active drug or a placebo with no active drug (2:1) via an IRT System and will apply the assigned study drug twice a day for up to 28 days. After the completion of dosing, the participants will be followed up for an additional 14 days. Participants in the Phase 1 portion of the study will also undergo PK evaluations at 2 study visits. |
| Intervention type | Drug |
| Phase | Phase I/II |
| Drug / device / biological / vaccine name(s) | PRA-523, Vehicle |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 69 Years |
| Sex | All |
| Target sample size at registration | 75 |
| Key inclusion criteria | 1. Age between 18-69 years 2. Atopic dermatitis, diagnosed for at least the previous 6 months 3. Current atopic dermatitis investigator’s global assessment (vIGA-AD) >=2 at screening and baseline (Day 1). 4. Body surface area affected by AD 2-25% at baseline and screening, excluding palms, scalp, soles, genitals and intertriginous areas 5. Minimum Peak pruritus numeric rating scale (PP-NRS) at screening and baseline (Day 1) and averaged over the run-in period. 6. Use of effective contraception for those of reproductive potential or those with partners of reproductive potential |
| Key exclusion criteria | 1. Unstable course of atopic dermatitis, in the opinion of the Investigator 2. Use of oral antihistamines (H1 and/or H2 blockers); e.g. diphenhydramine, loratadine, fexofenadine, cetirizine, famotidine) within 14 days of first dose. 3. Use of other (non-antihistamine) nonbiologic systemic treatment for atopic dermatitis (e.g. cyclosporine, methotrexate) including ultraviolet light therapy, for atopic dermatitis in 2 months prior to baseline 4. Use of biologic therapies for atopic dermatitis within 3 months of screening 5. Treatment with topical medication for AD within 14 days prior to Day 1. 6. Emollient use between Day -1 (day before first dose) and Visit 6 (last day of dosing) on affected skin identified for treatment at Baseline (or subsequent visits). Stable bland emollient use is permitted during the treatment period on skin areas untreated with IMP. 7. The presence of a skin condition which, in the opinion of the investigator, would interfere with the interpretation of the results or conduct of the trial, including, but not limited to keloids, hypertrophic scars, or other clearly defined etiology for pruritus other than atopic dermatitis |
| Date of first enrolment | 10/04/2026 |
| Date of final enrolment | 30/11/2026 |
Locations
Countries of recruitment
- New Zealand
Study participating centres
Grafton, Auckland
1010
New Zealand
Grafton, Auckland
1010
New Zealand
Christchurch Central City
8011
New Zealand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
13/04/2026: The Date of first enrolment was changed from 13/02/2026 to 10/04/2026
21/01/2026: Internal review.
16/01/2026: Trial's existence confirmed by Central Health and Disability Ethics Committees.
