A clinical study to determine the efficacy and safety of Tapinarof Cream 1% in patients with plaque psoriasis.
Scientific Title of Study
A PHASE III, MULTICENTRIC, COMPARATIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAPINAROF CREAM 1% IN COMPARISION WITH PLACEBO OF TAPINAROF CREAM 1% IN ADULT PATIENTS WITH PLAQUE
PSORIASIS.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICS/OPT/2025-002 V1.0 28 Mar 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
North West DELHI 110034 India
Phone
09868679414
Fax
Email
kartik.sahni@insigniacs.com
Details of Contact Person Scientific Query
Name
Mr Kartik Sahni
Designation
Director
Affiliation
Insignia Clinical Services Pvt. Ltd.
Address
#512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura
Once daily application to affected areas for 12 weeks
Intervention
TAPINAROF CREAM 1%
Once daily application to affected areas for 12 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of either gender, aged 18 to 65 years (both inclusive) and ready to give written informed consent to participate in the study.
2. Clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
3. Body surface area involvement more than equal to 3 percent and less than equal to 20 percent (the patients scalp, palms, groin, fingernails, toenails, and soles should be excluded from the %BSA calculations).
4. A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline (pre-randomization)
5. Women of childbearing potential must have a negative urine pregnancy test prior to study entry.
6. Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment.
ExclusionCriteria
Details
1. Known hypersensitivity to the drug components (study drug or excipient) used during the study.
2. Pregnant or lactating women.
3. Patients with non plaque forms of psoriasis (erythrodermic, guttate or pustular psoriasis).
4. Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
6. Concurrent conditions or history of other diseases
a) Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody at Screening visit.
b) Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Screening visit.
c) Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Screening visit.
d) Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator’s opinion, would make it difficult to interpret data or assessments during the study.
7. Use of any of the following medication within the indicated period before the Screening visit
a) Minimum of 5 half-lives for biologic agents- eg, 12 months for rituximab; 8 months for ustekinumab; 5 months for secukinumab; 12 weeks for golimumab; 10 weeks for ixekizumab; 8 weeks for infliximab, adalimumab, or alefacept; and 4 weeks for etanercept.
b) 4 weeks for systemic treatments: cyclosporin, interferon, methotrexate, apremilast, tofacitinib, mycophenolate, thioguanine, hydroxyurea, sirolimus, azathioprine, other systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs (more than 5000 IU^day), retinoids (eg, acitretin, isotretinoin), psoralens, corticosteroids, or adrenocorticotropic hormone analogs.
c) 2 weeks for immunizations with a live viral component, drugs known to possibly worsen psoriasis, such as beta-blockers (eg, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for more than 12 weeks.
d) With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, antihistamines, immunomodulators, anthralin (dithranol), Vitamin D derivatives (eg, calcipotriene, calcipotriol), retinoids (Note: 4 weeks for tazarotene), or coal tar.
8. Patients with active systemic infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 4 weeks of Day 1.
9. Patients have used topical therapy within 2 weeks of randomization or systemic therapy or phototherapy (i.e., UVB, PUVA) for psoriasis within 28 days of randomization.
10. Patients with active substance abuse or a history of substance abuse within 6 months prior to Screening.
11. Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix (surgical excision or electrodessication and curettage).
12. Concurrent skin lesions in the treatment area that, in the opinion of the Investigator, would either interfere with study evaluations or affect the safety of the patient.
13. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic,
psychiatric, or CV system abnormalities or laboratory abnormality that will affect the
health of the patient or interfere with interpretation of the results.
a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than equal to 2.5x the upper limit of normal (ULN), total bilirubin more than 1.5 x ULN, total bilirubin more than ULN and less than equal to 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less then 35 percent.
b) Corrected QT (QTcF) interval more than 475 msec.
14. Patient who has used any investigational drug or device within 30 days of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
15. Any observational finding (clinical evaluation or physical) that is interpreted by the medical researcher as a risk to the research participants participation in the clinical trial.
16. Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation).
17. Presence of any other dermatological condition that might confound the disease assessment and treatment evaluation.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients who achieve a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline.
Week 12
Secondary Outcome
Outcome
TimePoints
Proportion of patients with more than 50 percent improvement in Psoriasis Area and Severity Index from Baseline.
Week 12
Proportion of patients with more than 75 percent improvement in Psoriasis Area and Severity Index from Baseline.
Week 12
Proportion of patients with more than 90 percent improvement in Psoriasis Area and Severity Index from Baseline.
Week 12
Change in Peak Pruritus-Numeric Rating Scale (Peak Pruritus-NRS) from
Week 12
Change over time in psoriasis impact on daily activities, as measured by the Dermatology Life Quality Index (DLQI) total and individual dimension scores
Week 12
Change over time in psoriasis symptoms, as measured by the Psoriasis Symptom Diary (PSD)
Week 12
Change over time in physical component score and mental component score, as measured by the Short Form-36 (SF-36) questionnaire
Week 12
Incidence of TEAEs and SAEs
Throughout the study
Target Sample Size
Total Sample Size="213" Sample Size from India="213" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
26/11/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Psoriasis is a chronic, immune-mediated skin disease that affects
approximately 2% of persons worldwide. Topical therapies are the most preferred
management option but it is associated with poor adherence and low patient
satisfaction. Although existing topical therapies, including glucocorticoids,
are efficacious, especially in short-term treatment of localized disease, some
medications in this class have restrictions relating to duration and extent of
use and application sites.
Tapinarof is a non-steroidal, topical aryl hydrocarbon
receptor–modulating agent for the treatment of psoriasis. Tapinarof was found
to bind directly to AhR, resulting in the downregulation of inflammatory
cytokines, regulation of skin barrier protein expression, and antioxidant
activity.
Optimus Pharma Private Limited has developed Tapinarof Cream 1% and intends to conduct a
phase III clinical study in India. The present study has been planned to
compare the efficacy and safety of Tapinarof Cream 1% with that of a Placebo of
Tapinarof Cream 1% in the topical treatment of plaque psoriasis in adults.