Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
23-PPV · 1 trial · 1 indication
For participants with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive response was defined as an antibody titer \>/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers \>/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.
| Arm | Type | Description |
|---|---|---|
| Group A: OCR + Vaccines | EXPERIMENTAL | Participants will receive dual infusion of OCR 300 milligrams (mg) on Day 1 and then on Day 15, and then participants will further receive immunization course (TT-containing adsorbed vaccine, 23-PPV either unboosted or boosted with 13-PCV, influenza vaccine, and repeated administration with KLH) at 12 weeks post-OCR treatment until Week 24. Participants who complete the 24-week immunization study period will have the option for retreatment with a single infusion of 600 mg OCR on Day 169 and subsequent single infusions (600 mg OCR) at intervals of 24 weeks. Participants who have received one or more infusions of OCR will enter the 48-week safety follow-up period. |
| Group B: Vaccines (Optional OCR in Extension) | OTHER | Participants will receive immunizations (TT-containing adsorbed vaccine, 23-PPV, influenza vaccine, and repeated administration with KLH) on Day 1 until Week 12 of the immunization period. |
| Name | Type | Description |
|---|---|---|
| 23-PPV | BIOLOGICAL | The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B). |
| 13-PCV Booster | BIOLOGICAL | The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A). |
| Influenza Vaccine | BIOLOGICAL | The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B). |
| KLH | BIOLOGICAL | KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B). |
| OCR | DRUG | OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms. |
| TT Vaccine | BIOLOGICAL | The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B). |
Inclusion Criteria: * Diagnosis of RMS in accordance with the revised McDonald criteria * Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) * Expanded Disability Status Scale (EDSS) at Screening from ...
23-PPV is an investigational monoclonal antibody being studied for the treatment of relapsing-remitting multiple sclerosis, a form of multiple sclerosis characterized by episodes of new or worsening symptoms followed by periods of recovery. It is currently in Phase 3 clinical development.
23-PPV is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's effects in patients with relapsing forms of multiple sclerosis.
23-PPV is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its effects on immune responses in participants with relapsing-remitting multiple sclerosis.
23-PPV has one completed Phase 3 clinical trial registered under NCT02545868. The study, titled 'A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis,' enrolled 102 participants in the United States and Canada. The trial was controlled but not double-blinded.
The clinical trial for 23-PPV, identified as NCT02545868, is titled as a study of ocrelizumab. This indicates that 23-PPV may be an alternative name or identifier for ocrelizumab, a monoclonal antibody developed by Roche. The trial evaluated immune responses in participants with relapsing forms of multiple sclerosis.