Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06468228 | A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa | PHASE3 | ACTIVE NOT_RECRUITING | 1,400 | — | — | Jun 27, 2024 | Dec 1, 2026 | Jun 3, 2026 | 279 | United States, Argentina +42 |
| NCT06524635 | A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab | PHASE2 | RECRUITING | 60 | — | — | Aug 14, 2024 | Feb 1, 2027 | Jan 24, 2025 | 2 | United States |
| NCT05139602 | A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy | PHASE2 | ACTIVE NOT_RECRUITING | 210 | — | — | Dec 28, 2021 | Dec 1, 2027 | Feb 13, 2026 | 54 | United States, Australia +6 |
HiSCR 75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula count relative to baseline.
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 . |
| Period 2: Lutikizumab Every Week | EXPERIMENTAL | Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52 |
| Period 2: Lutikizumab Every Other Week | EXPERIMENTAL | Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52 |
| Period 2: Placebo to Lutikizumab Group | EXPERIMENTAL | Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week. |
| Period 2: Placebo to Lutikizumab Group Every Week | EXPERIMENTAL | Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52 |
| Period 2: Placebo to Lutikizumab Group Every Other Week | EXPERIMENTAL | The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52 |
| Period 3: Open-label Lutikizumab | EXPERIMENTAL | Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week |
| Sub-Study: Lutikizumab Pre-Filled Pen | EXPERIMENTAL | Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks. |
| SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve | EXPERIMENTAL | HS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration, with the option to enter an open-label LTE to continue to receive Lutikizumab Dose B at Week 16 and every week thereafter. |
| SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response | EXPERIMENTAL | Tumor Necrosis Factor-Inadequate Response (TNF-IR) participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration. |
| SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve | EXPERIMENTAL | AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration. |
| SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR) | EXPERIMENTAL | AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration. |
| Main Study: Lutikizumab Dose A | EXPERIMENTAL | Lutikizumab Dose A every week |
| Main Study: Lutikizumab Dose B | EXPERIMENTAL | Lutikizumab Dose B every other week |
| Main Study: Lutikizumab Dose C | EXPERIMENTAL | Lutikizumab Dose C every other week |
| Main Study: Placebo | PLACEBO_COMPARATOR | Placebo every week |
| Sub-study: Group 1 | EXPERIMENTAL | Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week. |
| Sub-study: Group 2 | EXPERIMENTAL | Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week. |
| Name | Type | Description |
|---|---|---|
| Lutikizumab | DRUG | Subcutaneous injection |
| Placebo | DRUG | Subcutaneous injection |
Inclusion Criteria: * Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant). * Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline * Hidradenitis suppurativa (HS) lesi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Lutikizumab, Upadacitinib |
| Incyte Corporation | INCY | 6 | PHASE3 | Povorcitinib, povorcitinib, Ruxolitinib, Vehicle |
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | secukinumab, Remibrutinib Dose A, Remibrutinib Dose B, CFZ533, LYS006 |
| MoonLake Immunotherapeutics Class A | MLTX | 4 | PHASE3 | Sonelokimab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE2 | Brivekimig, SAR445399 |
| Insmed Incorporated | INSM | 1 | PHASE2 | Brensocatib |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Eltrekibart |
| 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 Dose A, Tibulizumab Dose B |
| Sonoma Pharmaceuticals, Inc. | SNOA | 2 | PHASE1 | SBT777101 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |