Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Izokibep
ABY-035 · 3 trials · 3 indications
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
Complete Response is defined as Yes/No by visit by meeting at least 1 of the following criteria in at least one eye: 1. Inflammatory, chorioretinal and/or inflammatory retinal vascular lesions - No such active lesions; all prior lesions appear inactive 2. ACC Count - Trace or absent (0.5+ or 0) 3. Vitreous Haze - Trace or absent (0.5+ or 0)
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 |
|---|---|---|
| Part A (Open-label) izokibep every week | EXPERIMENTAL | Participants will receive izokibep every week from Day 1 through Week 31 |
| Part B (Double-blind) izokibep every week | EXPERIMENTAL | Participants will receive izokibep every week for 31 weeks. |
| Part B (Double-blind) izokibep every other week | EXPERIMENTAL | Participants will receive izokibep every other week for 30 weeks. |
| Part B (Double-blind) placebo every week | PLACEBO_COMPARATOR | Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31. |
| Part B (Double-blind) placebo every other week | PLACEBO_COMPARATOR | Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30. |
| Izokibep and maintenance corticosteroid dose | EXPERIMENTAL | Izokibep+ Prednisolon/Prednisone |
| 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 |
|---|---|---|
| Izokibep | DRUG | Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC) |
| Placebo to izokibep | DRUG | Form: Solution for injection Route of administration: Subcutaneous (SC) |
| Prednisone/Prednisolone | DRUG | Background Corticosteroid |
| ABY-035 | BIOLOGICAL | ABY-035 solution for injection |
| Placebo | BIOLOGICAL | Placebo to ABY-035 solution for injection |
Inclusion Criteria: General * Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * 18 years to 75 years of age Type of Subject and Disease Characteristics * Diagnosis o...
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| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 6 | PHASE3 | Risankizumab, Adalimumab, Lutikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 4 | PHASE3 | Zasocitinib |
| Johnson & Johnson | JNJ | 9 | PHASE3 | Guselkumab, Ustekinumab, Icotrokinra, JNJ-88545223 |
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Deucravacitinib |
| MoonLake Immunotherapeutics Class A | MLTX | 3 | PHASE3 | Sonelokimab |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Ixekizumab, Tirzepatide |
| Amgen Inc. | AMGN | 2 | PHASE3 | Apremilast |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE1 | Secukinumab |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Pfizer Inc. | PFE | 2 | - | tofacitinib |
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.