ELIGIBILITY

Aclaris Therapeutics, Inc. ("Aclaris") may support Investigator Initiated Studies (IIS) with drug supply, funding, material and/or information, as allowed under local laws and regulations, provided that they align with Aclaris' defined areas of strategic interest.

Types of IIS eligible for support:

  • Clinical studies of approved and investigational uses, involving marketed Aclaris drugs 

  • Clinical studies of drug products in development (interventional studies, non-clinical, phase I to IV)

  • Clinical observational studies, real-world evidence (non-interventional studies)

The following is out of scope:

  • Requests for compassionate use

 The sponsor/investigator has to fulfil (or agree to) the following requirements:

  • have the scientific, technical and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc.)
  • have expert statistical support
  • submit a scientifically well designed and well-written study proposal with well-defined research question (primary as well as secondary endpoints)
  • deliver to agreed timelines
  • be able to fulfill all regulatory requirements (including submitting a IND/CTA, writing of final study report and manuscripts etc.)
  • deliver a written report of the final study results to Aclaris
  • register the study on external website (e.g. clinicaltrials.gov) and publish the study in a scientific journal
  • agree to safety reporting to health authorities and to Aclaris
  • agree to provide study updates to Aclaris