Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1163 · 2 trials · 2 indications
Change from baseline in DAS28-CRP at Week 12.
To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
| Arm | Type | Description |
|---|---|---|
| AZD1163 Dose 1 | EXPERIMENTAL | Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24. |
| AZD1163 Dose 2 | EXPERIMENTAL | Participants will receive SC injection of AZD1163 Dose 2 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24. |
| AZD1163 Dose 3 | EXPERIMENTAL | Participants will receive SC injection of AZD1163 Dose 3 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive SC injection of placebo matched with AZD1163 dose in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24. |
| Part 1 Cohort 1 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 2 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 3 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 4 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5a SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5b SAD | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Cohort 6 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 7 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 8 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Pooled Placebo SAD IV | PLACEBO_COMPARATOR | Participants will receive matching IV infusion of placebo on Day 1. |
| Part 1 Placebo SAD SC | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Day 1. |
| Part 1 Cohort 9 SAD (Chinese Participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Placebo SAD (Chinese Participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Day 1. |
| Part 2 Cohort 1 MAD (Global) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 2 MAD (Global) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Global) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Cohort 3 MAD (Chinese Participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 4 MAD (Japanese participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Chinese participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Placebo MAD (Japanese participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Name | Type | Description |
|---|---|---|
| AZD1163 | DRUG | Participants will receive SC injection of one of three different doses of AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24. |
| Placebo | OTHER | Participants will receive SC injection of placebo matched to AZD1163 in combination with SoC (csDMARD or TNFi +/- csDMARDSoC) until Week 24. |
* Inclusion * Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening. * Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC; b. CRP \> upper limit of normal. ...
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AZD1163 is an investigational monoclonal antibody being studied for the treatment of rheumatoid arthritis. It is also being evaluated in healthy volunteers to assess its safety and tolerability. The drug is currently in clinical development and has not been approved by regulatory authorities.
AZD1163 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers and in patients with rheumatoid arthritis.
AZD1163 is in Phase 1 clinical development for healthy volunteers and Phase 2 clinical development for rheumatoid arthritis. A Phase 1 study has been completed, and a Phase 2 study is currently recruiting participants. The drug remains investigational and is not yet approved.
AZD1163 is being studied in two clinical trials. NCT06103877 is a completed Phase 1 placebo-controlled study of intravenous and subcutaneous AZD1163 in healthy volunteers. NCT07276581 is a recruiting Phase 2 study evaluating the efficacy and safety of AZD1163 in participants with rheumatoid arthritis.
AZD1163 is a distinct investigational monoclonal antibody developed by AstraZeneca. No alternative names for this drug have been reported in clinical trial registries. It is being studied under its own identifier across trials for healthy volunteers and rheumatoid arthritis.