INVESTIGATOR INITIATED STUDY (IIS)
Dermavant is currently supporting drug only requests for the use of tapinarof in investigator/externally led research programs in relevant therapeutic areas of interest. Funding for investigator initiated studies is not available at this time.
The objective of providing product, tapinarof, in relevant therapeutic areas of interest is to:
- Advance clinical research
- Enhance disease understanding and medical knowledge that may lead to improvements in clinical care
This program is open to healthcare providers, researchers and institutions interested in using tapinarof for external research within countries in which Dermavant has obtained regulatory approval.
Investigators and/or their affiliated institutions and networks assume responsibility for all aspects of the study, including design, regulatory submission, initiation, conduct, and monitoring of the research, along with data analysis and communication (e.g. abstract, manuscript, and final study report) of the results.
Proposals submitted to Dermavant are reviewed by Dermavant’s scientific and medical committee. Approval of a proposal is based on alignment with Dermavant’s IIS areas of interest, scientific merit, patient safety considerations, unmet medical need, study design, availability of resources, and feasibility of study conduct. Support for approved proposals may be provided in the form of study drug only at this time. Full approval is contingent upon a final approved protocol, regulatory clearance, Investigator Review Board approval, and full execution of a research agreement.
Current IIS areas of interest:
- Clinical studies focused on generation of data to provide clinicians further information on the role and appropriate use of tapinarof for the treatment of plaque psoriasis
- Studies to help advance understanding of the aryl hydrocarbon receptor (AhR) and its potential role in the treatment of inflammatory disorders
- Studies designed to assess burden and gaps in the treatment of plaque psoriasis and atopic dermatitis
Please submit all IIS proposals and / or inquiries via email at iis@dermavant.com
Download our corporate fact sheet