NCT06488664

An Efficacy and Safety Study of GNR-068 (Ustekinumab Biosimilar) and Stelara® in the Treatment of Patients With Moderate to Severe Plaque Psoriasis

Multicenter International Single-blind Randomized Comparative Clinical Study of the Efficacy and Safety of GNR-068 (45 mg) and Stelara® (45 mg) and Assessment of the Safety, Tolerability and Long-term Effectiveness of GNR-068 in Patients With Moderate and Severe Forms of Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized single-blind comparative parallel group efficacy and safety study of ustekinumab biosimilar GNR-068 (45 mg) and reference product Stelara® (45 mg) in the treatment of patients with moderate and severe forms of plaque psoriasis. Participants received a subcutaneous dose of ustekinumab 45 mg (GNR-068 or Stelara®) at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg. For patients with partially respond to the initial regimen the regimen can be adjusted.

Detailed description

The drug GNR-068 (INN: ustekinumab) is being developed as a biosimilar to the drug Stelara®, solution for subcutaneous administration (Silag AG, Switzerland). Preclinical studies and early phase clinical studies suggest that interleukins-12 (IL-12) and -23 (IL-23), two molecules that are part of the communication network in the immune system, may play an important role in psoriasis. Ustekinumab is a monoclonal antibody directed against IL-12 and IL-23. This is a randomized, single blind, parallel-group, multicenter study to determine the effectiveness and safety of ustekinumab biosimilar GNR-068 administered subcutaneously as compared with Stelara® in patients with moderate to severe plaque-type psoriasis. Patients receive GNR-068 45 mg or Stelara 45 mg administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28, thereafter until week 52 all patients receive GNR-068. For patients who partially respond to the initial regimen, the dose can be adjusted to 90 mg and then the interval can be adjusted to every 8 weeks. The study included a screening period, comparative treatment period, non-comparative treatment period, follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1. 422 patients (211 to each study groups) were randomized.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	GNR-068	GNR-068 was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 52.
BIOLOGICAL	Stelara®	Stelara® was administered subcutaneously at weeks 0 and 4 weeks then every 12 weeks thereafter until week 28 and then all patients receive GNR-068 45 mg until week 52.

Timeline

• Start date: 2023-07-25
• Primary completion: 2025-04-30
• Completion: 2025-09-30
• First posted: 2024-07-05
• Last updated: 2025-07-30

Locations

34 sites across 1 country: Russia