Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Molecure S.A.
Study ID
NCT06205121
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Pulmonary Sarcoidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OATD-01 — DRUG
    OATD-01 is an oral inhibitor of chitinase-1 (CHIT1)
  • Placebo — DRUG
    Matching placebo tablets

Study Details

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.

Key Dates

Start date
Mar 21, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Response to treatment [ Time Frame: After 12 weeks of treatment, i.e. from baseline (randomization) visit to End-of-Treatment (EOT) visit. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Molecure Investigative SiteBirminghamAlabama35209-
Molecure Investigative SiteKansas CityKansas66062-
Molecure Investigative SiteBaltimoreMaryland21224-
Molecure Investigative SiteRochesterMinnesota55905-
Molecure Investigative SiteClevelandOhio44195-
Molecure Investigative SitePhiladelphiaPennsylvania19140-
Molecure Investigative SiteCharlestonSouth Carolina29425-

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