TCK-276 / Teijin - LARVOL DELTA

A double-blind, placebo-controlled, randomized multiple dose phase 1b trial of a CDK4/6 inhibitor, TCK-276, in patients with active rheumatoid arthritis. (PubMed, Rheumatology (Oxford)) - P1 | "TCK-276 (≤175 mg) was well tolerated with no clinically meaningful safety signals in patients with active RA. Together with the preliminary efficacy (≥25 mg/day), these data warrant further study of TCK-276 for the treatment of active RA."

Journal • P1 data • Hematological Disorders • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety, Tolerability, and Pharmacokinetics of a Novel Synthetic Disease Modifying Antirheumatic Drug, TCK-276, After Single Ascending Dose in Healthy Subjects and Multiple Ascending Doses in Patients with Rheumatoid Arthritis (ACR Convergence 2023) - P1 | "Safety results indicated that TCK-276 was well tolerated at a dose of up to 185 mg for a single administration and up to 25 mg/day over 7 days of administration. In addition, no safety concerns have been observed such as anemia, neutropenia, leukopenia, and thrombocytopenia, which are often observed with other CDK4/6 inhibitors. TCK-276 showed faster elimination than other CDK4/6 inhibitors, which may be related to the observed safety profile."

Clinical • PK/PD data • Anemia • Hematological Disorders • Immunology • Inflammatory Arthritis • Leukopenia • Neutropenia • Pain • Rheumatoid Arthritis • Rheumatology • Thrombocytopenia

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Teijin America, Inc. | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Teijin America, Inc. | Trial completion date: Jan 2023 ➔ Jun 2023 | Trial primary completion date: Jan 2023 ➔ Jun 2023

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Teijin America, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Teijin America, Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology