A Randomized, Placebo-Controlled, Parallel-Design, Exploratory Study to Evaluate the Efficacy of fremanezumab in Subjects with Rosacea

Study identification

• EU PAS number:
  EUPAS41590
• Study ID:
  46596
• Official title and acronym:
  A Randomized, Placebo-Controlled, Parallel-Design, Exploratory Study to Evaluate the Efficacy of fremanezumab in Subjects with Rosacea
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Lay language title: A study of fremanezumab in patients with moderate to severe rosacea Phase 1b interventional study Inclusion: Males and non-pregnant females with moderate or severe rosacea, 18 years and older Exclusion: Other rosacea treatments within 14 days Known sensitivity to fremanezumab Study completion expected November 2021 IPD sharing statement: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email [e-mail] to make your request.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:06/01/2021

Actual:02/02/2021

Study start date

Planned:16/06/2021

Actual:16/06/2021

Date of final study report

Planned:15/02/2022

Actual:22/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

TV48125-SP-10178