A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a 12-week Administration of OATD-01, an Oral Inhibitor of Chitinase-1 (CHIT1), for the Treatment of Active Pulmonary Sarcoidosis (the KITE Study)
Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2, randomized, double-blind, placebo-controlled, adaptive, multicenter study to evaluate the efficacy, safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of OATD-01 in the treatment of subjects with active pulmonary sarcoidosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines)
• Treatment-naïve or previously treated (no recruitment cap)
• Parenchymal pulmonary involvement on \[18F\]FDG PET/CT
Locations
United States
Alabama
Molecure Investigative Site
WITHDRAWN
Birmingham
Kansas
Molecure Investigative Site
WITHDRAWN
Kansas City
Maryland
Molecure Investigative Site
RECRUITING
Baltimore
Minnesota
Molecure Investigative Site
WITHDRAWN
Rochester
Ohio
Molecure Investigative Site
RECRUITING
Cleveland
Pennsylvania
Molecure Investigative Site
RECRUITING
Philadelphia
South Carolina
Molecure Investigative Site
RECRUITING
Charleston
Other Locations
Denmark
Molecure Investigative Site
WITHDRAWN
Vejle
France
Molecure Investigative Site
WITHDRAWN
Bobigny
Molecure Investigative Site
RECRUITING
Montpellier
Molecure Investigative Site
RECRUITING
Paris
Molecure Investigative Site
RECRUITING
Paris
Germany
Molecure Investigative Site
RECRUITING
Essen
Molecure Investigative Site
RECRUITING
Freiburg Im Breisgau
Molecure Investigative Site
RECRUITING
Mainz-ge
Greece
Molecure Investigative Site
WITHDRAWN
Corfu
Molecure Investigative Site
RECRUITING
Heraklion
Molecure Investigative Site
RECRUITING
Pátrai
Molecure Investigative Site
RECRUITING
Thessaloniki
Netherlands
Molecure Investigative Site
RECRUITING
Nieuwegein
Molecure Investigative Site
RECRUITING
Rotterdam
Norway
Molecure Investigative Site
RECRUITING
Bergen
Molecure Investigative Site
RECRUITING
Oslo
United Kingdom
Molecure Investigative Site
RECRUITING
Birmingham
Molecure Investigative Site
WITHDRAWN
Cambridge
Molecure Investigative Site
RECRUITING
Edinburgh
Molecure Investigative Site
RECRUITING
London
Molecure Investigative Site
RECRUITING
London
Contact Information
Primary
Theodoros Charitos, MD
t.charitos@molecure.com
+48789125928
Time Frame
Start Date: 2024-03-21
Estimated Completion Date: 2027-09
Participants
Target number of participants: 96
Treatments
Experimental: Active Arm
Subjects will receive OATD-01 as 25mg film-coated tablets for oral administration once daily for 12 weeks
Placebo_comparator: Placebo Arm
Subjects will receive placebo as film-coated tablets for oral administration once daily for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Molecure S.A.