drugset / Trial / NCT03595618
A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis
Phase 2
Completed
932 enrolled
Lakefront Biotherapeutics NV
Institut de Recherches Internationales Servier · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
Timeline
- Start
- 2018-08-14
- Primary completion
- 2020-07-14
- Completion
- 2020-07-14
Outcome
Missed primary endpoint
registry analysis (superiority test); GLPG1972 75 mg vs Placebo; p = 0.165; Adjusted mean difference 0.04514 (95% CI -0.00317 to 0.09345) NCT03595618 ↗
registry analysis (superiority test); GLPG1972 150 mg vs Placebo; p = 0.939; Adjusted mean difference 0.01200 (95% CI -0.03868 to 0.06267) NCT03595618 ↗
registry analysis (superiority test); GLPG1972 300 mg vs Placebo; p = 0.682; Adjusted mean difference 0.02329 (95% CI -0.02641 to 0.07300) NCT03595618 ↗
Publications
- Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
- Larsson S, Lalande A, Stefan Lohmander L, Soret P, Bernard K, Pueyo M, Struglics A. Serum ARGS-aggrecan in a phase 2 clinical trial targeting osteoarthritis. Osteoarthritis Cartilage. 2024 Nov;32(11):1463-1470. doi: 10.1016/j.joca.2024.06.003. Epub 2024 Jun 9.
- Schnitzer T, Pueyo M, Deckx H, van der Aar E, Bernard K, Hatch S, van der Stoep M, Grankov S, Phung D, Imbert O, Chimits D, Muller K, Hochberg MC, Bliddal H, Wirth W, Eckstein F, Conaghan PG. Evaluation of S201086/GLPG1972, an ADAMTS-5 inhibitor, for the treatment of knee osteoarthritis in ROCCELLA: a phase 2 randomized clinical trial. Osteoarthritis Cartilage. 2023 Jul;31(7):985-994. doi: 10.1016/j.joca.2023.04.001. Epub 2023 Apr 13.
- Brebion F, Gosmini R, Deprez P, Varin M, Peixoto C, Alvey L, Jary H, Bienvenu N, Triballeau N, Blanque R, Cottereaux C, Christophe T, Vandervoort N, Mollat P, Touitou R, Leonard P, De Ceuninck F, Botez I, Monjardet A, van der Aar E, Amantini D. Discovery of GLPG1972/S201086, a Potent, Selective, and Orally Bioavailable ADAMTS-5 Inhibitor for the Treatment of Osteoarthritis. J Med Chem. 2021 Mar 25;64(6):2937-2952. doi: 10.1021/acs.jmedchem.0c02008. Epub 2021 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALDUMASTAT | Small molecule | 75 mg | Oral |
| Subject | ALDUMASTAT | Small molecule | 150 mg | Oral |
| Subject | ALDUMASTAT | Small molecule | 300 mg | Oral |