Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06205121
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-12-13
Brief Title:
Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis
Sponsor:
Molecure SA
Organization:
Molecure SA
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Adult subjects 18 years of age diagnosed with symptomatic pulmonary sarcoidosis and active granulomatous process captured by 18FFluorodeoxyglucose Positron emission tomographycomputed tomography 18FFDG PETCT imaging treatment-naïve or previously treated but currently untreated will be enrolled in the study The diagnosis of pulmonary sarcoidosis will be based on the diagnostic criteria for pulmonary sarcoidosis recommended by the American Thoracic Society ATS 2020
Subjects will be randomized in a 11 ratio to receive either OATD-01 or placebo for 12 weeks A stratification of the study population based on previous treatment status for sarcoidosis previously treatedtreatment-naïve will be applied for statistical analysis without limitation for the ratio between the subject groups Double-blind conditions will be kept for the whole treatment duration
Subjects will be randomized in a 11 ratio to receive either OATD-01 or placebo for 12 weeks A stratification of the study population based on previous treatment status for sarcoidosis previously treatedtreatment-naïve will be applied for statistical analysis without limitation for the ratio between the subject groups Double-blind conditions will be kept for the whole treatment duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506642-23 | EUDRACT_NUMBER | None | None |