Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Astegolimab · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Open-Label Extension | EXPERIMENTAL | Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study |
| Astegolimab SC Q2W | EXPERIMENTAL | Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) |
| Astegolimab SC Q4W | EXPERIMENTAL | Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W. |
| Placebo SC Q2W | PLACEBO_COMPARATOR | Participants will receive SC placebo Q2W |
| Astegolimab Q2W | EXPERIMENTAL | Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W). |
| Astegolimab Q4W | EXPERIMENTAL | Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive SC placebo Q2W. |
| Treatment A | EXPERIMENTAL | Participants will receive one subcutaneous (SC) dose in the abdomen. |
| Treatment B | EXPERIMENTAL | Participants will receive one subcutaneous (SC) dose in the thigh. |
| Treatment C | EXPERIMENTAL | Participants will receive one subcutaneous (SC) dose in the upper arm. |
| Name | Type | Description |
|---|---|---|
| Astegolimab | DRUG | Participants will receive SC astegolimab Q2W |
| Placebo | DRUG | Participants will receive SC placebo Q2W |
Inclusion Criteria: * Completion of the 52-week treatment period in either parent GB43311 or GB44332 Exclusion Criteria: * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * Significant non-compliance in the par...
Astegolimab is an investigational monoclonal antibody being developed for the treatment of chronic obstructive pulmonary disease (COPD). It has also been studied in healthy volunteers in a pharmacokinetic trial. It is not approved for any indication and remains in clinical development.
Astegolimab targets IL1RAP and IL1RL1, acting as an inhibitor of this receptor pathway. IL1RL1 is also known as ST2, the receptor for IL-33, a cytokine involved in airway inflammation. By blocking this signaling axis, astegolimab is designed to dampen inflammation relevant to COPD.
Astegolimab is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is running the clinical development program, including the Phase 3 COPD trials and the completed Phase 1 healthy volunteer study.
Astegolimab is in Phase 3 development for chronic obstructive pulmonary disease. Two Phase 3 trials are active but no longer recruiting, and a Phase 2 COPD trial and a Phase 1 healthy volunteer study have been completed. The drug is investigational and has not been approved by the FDA.
Astegolimab has been studied in four trials. The Phase 3 COPD studies are NCT05878769, a long-term safety trial with 2,000 participants, and NCT05595642, with 1,290 participants. The completed Phase 2 COPD trial is NCT05037929, and the completed Phase 1 healthy volunteer study is NCT06462118.
Across the four listed trials, total enrollment is 4,624 participants. The Phase 3 long-term safety study NCT05878769 enrolled 2,000 participants, the Phase 3 study NCT05595642 enrolled 1,290, the completed Phase 2 trial NCT05037929 enrolled 1,334, and the Phase 1 study NCT06462118 enrolled 78 healthy volunteers.