A study to assess the efficacy & safety of OATD-01 for the treatment of active pulmonary sarcoidosis
Research type
Research Study
Full title
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)
IRAS ID
1008468
Contact name
Theodore Charitos
Contact email
Sponsor organisation
Molecure S. A.
Eudract number
2023-506642-23
ISRCTN Number
ISRCTN16728593
Clinicaltrials.gov Identifier
N/A
Research summary
The study will test OATD-01, an experimental medicine, for the first time in patients with pulmonary sarcoidosis. The study goal is to evaluate OATD-01 in the reduction of inflammation and assessing OATD-01 safety.
OATD-01 is a novel small-molecule, which affects the activity of CHIT1. CHIT1 also known as chitotriosidase is an enzyme (a catalyst of chemical reactions) which has shown to be involved in several lung diseases including pulmonary sarcoidosis. Therefore OATD-01 blocks this enzyme to reduce inflammation.
OATD-01 has been tested in 129 healthy volunteers and has been shown to block CHIT1. It has also shown that it has an acceptable safety level to move to the next stage of clinical trials.
Up to 30 days of screening, twelve weeks of treatment and 4 weeks FUP after last dose per subject that is not withdrawn prematurely (subject to one or more unscheduled FUP visits in case of premature withdrawal from the study treatment due to an AE that has not resolved or stabilized by W12). Total study duration between first subject first visit and last subject last visit about 15 months.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0237
Date of REC Opinion
13 Nov 2023
REC opinion
Further Information Favourable Opinion