Plaque PsoriasisPhase 3NCT05172726
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
A Phase 3 study testing tapinarof cream, 1% in people with Plaque Psoriasis, run by Organon and Co at 19 sites in 2 countries.
Trial summary
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- tapinarof cream, 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 2 Dec 2021to 14 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
- Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
- A PGA score of ≥ 2 at screening and baseline
- Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- Must not be pregnant
- Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
Who cannot join
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Immunocompromised at screening
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
- Screening total bilirubin > 1.5x ULN
- Current or chronic history of liver disease
Show all 14Show fewer
- Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- Major surgery within 8 weeks prior to baseline or has a major surgery planned during the study
- Known history of clinically significant drug or alcohol abuse in the last year prior to baseline
- Use of any prohibited medication or procedure within the indicated period before the baseline visit until the completion of the study completion or study discontinuation
- History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion may interfere with the subject's participation in the study, interpretation of results, safety of the subject or ability to understand and give informed consent
- Pregnant or lactating females.
- History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
- Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States12 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Wright State Physicians Pharmacology Translational Unit
Fairborn, Ohio, 45324
First OC Dermatology
Fountain Valley, California, 92708
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250
RM Medical Research
Miami Lakes, Florida, 33014
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Mission Dermatology Center
Rancho Santa Margarita, California, 92688
Northwest Arkansas Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Olympian Clinical Research
Tampa, Florida, 33615
Options Research Group
West Lafayette, Indiana, 47906
Canada7 sites
Dermatology Research Institute Inc.
Calgary, Alberta, T2J7E1
Rejuvenation Laser Dermatology Clinics
Edmonton, Alberta, T5J3S9
Lynderm Research Inc.
Markham, Ontario, L3P1X3
Innovaderm Research, Inc.
Montreal, Quebec, H2X 2V1
Skincare Studio INC
St. John's, Newfoundland and Labrador, A1E1V4
Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4
Whitby Health Centre Dermatology Trials
Whitby, Ontario, L1P0P9
About this study
Official title: A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
This is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Read the detailed description
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.
- Conditions
- Plaque Psoriasis
- Being tested
- tapinarof cream, 1%
- Keywords
- plaque psoriasis, pediatric, phase 3, topical, tapinarof
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapinarof cream, 1%Drug
applied topically once daily
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Not described Receives: Drug: tapinarof cream, 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Measured: Screening up to Week 53
Number of subjects with clinically significant laboratory test abnormalities
Measured: Screening up to Week 53
Number of subjects with clinically significant vital signs abnormalities
Measured: Screening up to Week 53
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Measured: Baseline up to Week 52
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Measured: Baseline up to Week 52
Secondary outcomes (3)
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point.
Measured: Week 4 and Week 12
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Maximum observed plasma concentration (Cmax).
Measured: Week 4 and Week 12
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Time to maximum observed plasma concentration obtained directly from the observed concentration.
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start2 Dec 2021
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Lead Late-Stage Clinical Development, Study director, Organon and Co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172726
- Sponsor's protocol ID
- DMVT-505-3004
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.
PubMed 38777187
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT05172726
- Acronym / sponsor ID
- DMVT-505-3004
- Conditions
- Plaque Psoriasis
- Keywords
- plaque psoriasis, pediatric, phase 3, topical, tapinarof
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 29 Dec 2021 (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 is an open-label, multi-center, Phase 3 study to evaluate tapinarof cream, 1% in pediatric subjects with plaque psoriasis.
Detailed description
This study is an open-label study, consisting of a 12-week primary treatment phase and an optional 40-week long-term extension phase in which all eligible subjects will receive tapinarof cream, 1% once daily. At the end of the 12-week primary treatment phase subjects will have the option to continue for 40 additional weeks of treatment. Subjects who choose not to participate in the optional 40-week long-term extension phase will complete a follow-up visit approximately one week after the end of the primary treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: tapinarof cream, 1% |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female subjects ages 2 to 17 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 3 months prior to the baseline visit
- Subject with plaque psoriasis covering ≥ 3% of the BSA at screening and baseline
- A PGA score of ≥ 2 at screening and baseline
- Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- Must not be pregnant
Key exclusion criteria (14 listed)
- Psoriasis other than plaque variant
- Any sign of infection of any of the psoriatic lesions
- Immunocompromised at screening
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN)
- Screening total bilirubin > 1.5x ULN
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 |
|---|---|---|
| tapinarof cream, 1%applied topically once daily | Drug | Open Label |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to Week 53
Incidence, frequency, and duration of treatment emergent AEs and SAEs
Number of subjects with clinically significant laboratory test abnormalities
Time frame: Screening up to Week 53
Number of subjects with clinically significant vital signs abnormalities
Time frame: Screening up to Week 53
Investigator-Assessed Local Tolerability Scale (LTS) Scores
Time frame: Baseline up to Week 52
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Subject (or Caregiver)-Assessed Local Tolerability Scale (LTS)
Time frame: Baseline up to Week 52
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
3 secondary outcomes
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Detectable Time-Point (AUC0-t) of tapinarof cream, 1%.
Time frame: Week 4 and Week 12
Maximum Plasma Concentration (Cmax) of tapinarof cream, 1%.
Time frame: Week 4 and Week 12
Time to Maximum Plasma Concentration (tmax) of tapinarof cream, 1%.
Time frame: Week 4 and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 38777187Silverberg JI, Eichenfield LF, Hebert AA, Simpson EL, Stein Gold L, Bissonnette R, Papp KA, Browning J, Kwong P, Korman NJ, Brown PM, Rubenstein DS, Piscitelli SC, Somerville MC, Tallman AM, Kircik L. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465. doi: 10.1016/j.jaad.2024.05.023. Epub 2024 May 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Clinical Lead Late-Stage Clinical Development study director
Organon and Co
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tapinarof cream, 1% in people with Plaque Psoriasis, run by Organon and Co at 19 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Screening up to Week 53). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172726, which also lists 1 linked publication.
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 5 Nov 2026.