Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABY-035
Izokibep · 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...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
Izokibep is an investigational therapy being studied for hidradenitis suppurativa and uveitis. It is not yet approved for any indication. Clinical development has focused on these inflammatory conditions, with a completed Phase 2b trial in hidradenitis suppurativa and a completed Phase 2 trial in non-anterior uveitis.
Izokibep targets interleukin-17A (IL-17A). It is an IL-17A inhibitor, a class of agents that block this inflammatory cytokine. By inhibiting IL-17A, izokibep is designed to reduce inflammation associated with conditions such as hidradenitis suppurativa and uveitis.
Izokibep is being developed by ACELYRIN, INC., which trades on the Nasdaq under the ticker SLRN. The company is responsible for the clinical program evaluating izokibep in hidradenitis suppurativa and uveitis.
Izokibep is in Phase 2 clinical development. It has completed a Phase 2b trial in hidradenitis suppurativa and a Phase 2 trial in non-anterior uveitis. The drug remains investigational and has not been approved by the FDA for any indication.
Izokibep has been evaluated in two completed Phase 2 trials. NCT05355805 was a Phase 2b study in hidradenitis suppurativa that enrolled 205 patients across the United States, Canada, Germany, Hungary, Poland, and Spain. NCT04706741 was a Phase 2 trial in non-anterior uveitis conducted in the United States.