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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