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Dose-response Relationship Study of S42909 on Leg Ulcer Healing

NCT03077165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-10-08

Study results available
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Summary

Dose-response relationship study of S42909 on leg ulcer healing after oral repeated administration in patients with active venous leg ulcer.

Conditions

  • Venous Leg Ulcer

Interventions

DRUG

S42909 100 mg

50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

DRUG

S42909 200 mg

50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

DRUG

S42909 400 mg

200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

DRUG

S42909 800 mg

200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.

DRUG

S42909 1200 mg

200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.

DRUG

Placebo Oral Tablet

Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.

Sponsors & Collaborators

  • Ilkos Therapeutic Inc.

    lead INDUSTRY

Principal Investigators

  • Eberhard Rabe, Professor · Department of Dermatology University of Bonn

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2019-12-12
Completion
2020-01-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Canada
  • Czechia
  • Hungary
  • Italy
  • Poland
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03077165 on ClinicalTrials.gov