Film-coated tablet

DRUG5 trials

Sponsors

Kartos Therapeutics Inc., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Horizon Therapeutics Ireland Designated Activity Company, LG Chem

Conditions

Diffuse Cutaneous Systemic SclerosisIdiopathic Pulmonary FibrosisPrimary MyelofibrosisSecondary Myelofibrosis (including but not limited to myelofibrosis post-Polycythemia Vera or post-Essential Thrombocythemia)Ulcerative Colitisidiopathic pulmonary fibrosis

Phase 1

Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of LC51-0255 Film-coated Tablet (SG85) With LC51-0255 Uncoated Tablet (SG82) in Healthy Subjects

CompletedNCT04360343

LG ChemUlcerative Colitis

Start: 2020-07-01End: 2020-12-01Updated: 2021-01-22

Phase 2

A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis

CompletedCTIS2023-509784-24-00

Horizon Therapeutics Ireland Designated Activity CompanyIdiopathic Pulmonary Fibrosis

Start: 2022-05-11End: 2024-10-30Target: 17Updated: 2024-12-18

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis [HZNP-HZN-825-301]

CompletedCTIS2023-509782-20-00

Horizon Therapeutics Ireland Designated Activity CompanyDiffuse Cutaneous Systemic Sclerosis

Start: 2021-11-11End: 2024-12-19Target: 84Updated: 2025-02-25

A randomised, double-blind, placebo-controlled, dose-finding study evaluating efficacy, safety and tolerability of different doses of BI 1819479 over at least 24 weeks in patients with idiopathic pulmonary fibrosis (IPF).

CompletedCTIS2023-508395-11-00

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.idiopathic pulmonary fibrosis

Start: 2024-09-10End: 2026-01-09Target: 123Updated: 2025-12-22

Phase 3

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

RecruitingCTIS2023-504724-25-00

Kartos Therapeutics Inc.Primary Myelofibrosis, Secondary Myelofibrosis (including but not limited to myelofibrosis post-Polycythemia Vera or post-Essential Thrombocythemia)

Start: 2024-10-16Target: 126Updated: 2025-10-06

Related Papers

POIESIS: a phase III study of add-on navtemadlin in JAK inhibitor-naïve myelofibrosis patients with a suboptimal response to ruxolitinib.

2026-03-07