Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABY-035 · 1 trial · 1 indication
ACR50 response rate at V9 (Week 16) for higher Dose vs. Placebo
ACR50 response rate at V7 (Week 12) for higher Dose vs. Placebo
| Arm | Type | Description |
|---|---|---|
| ABY-035 40 mg | EXPERIMENTAL | 40 mg ABY-035 SC |
| ABY-035 80 mg | EXPERIMENTAL | 80 mg ABY-035 SC |
| Placebo | PLACEBO_COMPARATOR | Placebo, switching to 80 mg ABY-035 after 16 weeks |
| Name | Type | Description |
|---|---|---|
| ABY-035 | BIOLOGICAL | ABY-035 solution for injection |
| Placebo | BIOLOGICAL | Placebo to ABY-035 solution for injection |
Inclusion criteria: * Patient who has given his / her signed declaration of consent and data protection declaration * At least 18 years and less than 75 years of age at Screening visit * Psoriatic arthritis with inflammatory musculoskeletal disease (joint, spine, or entheseal) with the presence of ...
ABY-035 is an investigational monoclonal antibody being studied for the treatment of active psoriatic arthritis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated for its efficacy, tolerability, and safety in patients with this condition.
ABY-035 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating psoriatic arthritis, an autoimmune condition, but the exact mechanism of action is not publicly detailed.
ABY-035 is being developed by ACELYRIN, INC., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol SLRN. ACELYRIN is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for psoriatic arthritis.
ABY-035 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in patients with active psoriatic arthritis to assess its efficacy, tolerability, and safety profile.
ABY-035 has one completed Phase 2 clinical trial with the identifier NCT04713072. This study investigated the efficacy, tolerability, and safety of ABY-035 in patients with active psoriatic arthritis. The trial enrolled 129 participants and was conducted across multiple European countries, including Austria, Belgium, Czechia, Germany, Hungary, Poland, and Spain.
No alternative names for ABY-035 have been reported. The drug is known only by its developmental code name ABY-035 and is being investigated by ACELYRIN, INC. for the treatment of psoriatic arthritis. It is a monoclonal antibody in Phase 2 clinical trials.