Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olokizumab q4w · 1 trial · 1 indication
Incidence of Treatment-Emergent Adverse Events Reported for ≥5% of Subjects in Any Treatment Group by System Organ Class or Preferred Term
Incidence of Serious Treatment-Emergent Adverse Events by System Organ Class or Preferred Term. Deaths are included.
Incidence Rate of all Subjects with at Least One Treatment Emergent AE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Incidence Rate of all Subjects with at Least One Treatment Emergent SAE. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
Incidence Rate of all Subjects with at Least One Treatment Emergent AESI. Subject Incidence Rate (IR) is summarized per 100 subject years (SY) of follow-up (/100 SY) based on the OLE safety population and presented by study treatments.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1: OKZ 64 mg q4w + MTX | EXPERIMENTAL | Olokizumab 64 mg SC q4w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). |
| Treatment Arm 2: OKZ 64 mg q2w + MTX | EXPERIMENTAL | Olokizumab 64 mg SC q2w + concomitant background therapy (Methotrexate) at a stable dose with a stable route of administration (oral, subcutaneous, or intramuscular). |
| Name | Type | Description |
|---|---|---|
| Olokizumab 64 mg SC q4w | DRUG | 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS).PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| Olokizumab 64 mg SC q2w | DRUG | 160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial with target volume of 0.4 mL or in the pre-filled syringe (PFS). PFS is composed of a 1 mL clear Type I glass barrel vial with target volume of 0.4 mL. |
| Concomitant treatment | DRUG | Methotrexate 15 to 25 mg/week (or ≥ 10 mg/week if there was documented intolerance to higher doses). (Subject maintained their stable dose and route (oral, SC, or IM) during the core study and for ≥ 12 additional weeks of OLE.) Folic acid ≥ 5 mg per week or equivalent |
Inclusion Criteria: Subjects may be enrolled in the study only if they meet all of the following criteria: 1. Subject must be willing and able to sign informed consent 2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL...
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Olokizumab q4w is an investigational drug being studied for the treatment of moderately to severely active rheumatoid arthritis. It is in Phase 3 clinical development and is not yet approved by regulatory authorities.
Olokizumab q4w is being developed by IQVIA Holdings, Inc., a company traded on the New York Stock Exchange under the ticker symbol IQV.
Olokizumab q4w is in Phase 3 clinical development for rheumatoid arthritis. It is an investigational drug and has not been approved for commercial use.
Olokizumab q4w is being studied in a Phase 3 clinical trial registered as NCT03120949, titled "Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis." This trial has been completed and enrolled 2,106 participants.
Yes, Olokizumab q4w is a small molecule drug. It is being developed as a therapeutic option for rheumatoid arthritis, an autoimmune condition affecting the joints.
The Phase 3 trial for Olokizumab q4w (NCT03120949) enrolled 2,106 participants with moderately to severely active rheumatoid arthritis. The trial was randomized and controlled, and it included sites in multiple countries across the Americas, Europe, and Asia.