Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488664
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-28
Brief Title:
An Efficacy and Safety Study of GNR-068 Ustekinumab Biosimilar and Stelara in the Treatment of Patients With Moderate to Severe Plaque Psoriasis
Sponsor:
AO GENERIUM
Organization:
AO GENERIUM
Study Overview
Official Title:
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 422 patients 211 to each study groups were randomized
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 11 422 patients 211 to each study groups were randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None