NCT06103695

Brief Summary

Open label study to assess 12 weeks of add-on VTAMA® (tapinarof) Cream, 1% QD in patients with ≥3% BSA who have received biologic therapy for at least 24 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 19, 2023

Last Update Submit

October 19, 2023

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Body surface area ≤1%

    Patients who achieve body surface area of ≤1%

    12 weeks

Study Arms (1)

Vtama

OTHER

open label Vtama

Drug: Tapinarof

Interventions

TapinarofDRUG

Add on Vtama (tapinarof) to biololgic therapy

Vtama

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adult ≥ 18 years of age;
  • Diagnosis of chronic plaque-type
  • Patient with ≥3% BSA
  • Patient has been treated with biologic for a minimum of 24 weeks
  • Able and willing to give written informed consent prior to performance of any study-related procedures.

You may not qualify if:

  • ≤3% BSA
  • Patient not receiving biologic agent, or receiving biologic agent \<24weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schweiger Derm Group

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 27, 2023

Study Start

February 27, 2023

Primary Completion

October 18, 2023

Study Completion

October 18, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)