Styleikin (ustekinumab biosimilar) / Generium - LARVOL DELTA

UKM-PS-III: An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=422 | Completed | Sponsor: AO GENERIUM | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Psoriatic Arthritis

An Open-Label, Comparative, Parallel Clinical Trial of the Safety, Pharmacokinetics and Immunogenicity of the Ustekinumab Biosimilar GNR-068 and the Originally Developed Ustekinumab as a Reference Drug After a Single Subcutaneous Administration in Healthy Male Volunteers. (PubMed, Antibodies (Basel)) - "Adverse events were similar between treatment groups and consistent with the safety profile of the ustekinumab RP. These results indicate that GNR-068 and the ustekinumab RP share similar PK and safety profiles."

Journal • PK/PD data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Ulcerative Colitis • IL12A

UKM-PS-III: An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=422 | Active, not recruiting | Sponsor: AO GENERIUM | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

UKM-PS-III: An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=422 | Active, not recruiting | Sponsor: AO GENERIUM

New P3 trial • Dermatology • Immunology • Psoriasis

A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=122 | Completed | Sponsor: AO GENERIUM

New P1 trial