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Hidradenitis Suppurativa Phase 2b Study of Izokibep
Phase 2 trial testing Izokibep in Hidradenitis Suppurativa in 205 participants. Completed in 21 February 2024.
| Lead sponsor | ACELYRIN Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 205 |
| Start date | 5 May 2022 |
| Primary completion | 2 August 2023 |
| Estimated completion | 21 February 2024 |
| Sites | 44 locations across Germany, Poland, Hungary, Canada, United States, Spain |
ACELYRIN Inc. — full company profile →
Adults 18 to 75, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 12 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 16 | |
| Part B Izokibep 160 mg QW | 21 | |
| Part B Izokibep 160 mg Q2W | 19 |
An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 26 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 2 |
Blood samples were collected at different time points throughout the study.
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 15 |
| Group | Value | 95% CI |
|---|---|---|
| Part A Izokibep 160 mg QW | 17 |
HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 9 | |
| Part B Izokibep 160 mg QW | 15 | |
| Part B Izokibep 160 mg Q2W | 12 |
HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 7 | |
| Part B Izokibep 160 mg QW | 15 | |
| Part B Izokibep 160 mg Q2W | 11 |
HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 22 | |
| Part B Izokibep 160 mg QW | 26 | |
| Part B Izokibep 160 mg Q2W | 26 |
A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline. Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus c
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 22.32 | 11.7 – 32.9 |
| Part B Izokibep 160 mg QW | 18.29 | 8.43 – 28.1 |
| Part B Izokibep 160 mg Q2W | 14.93 | 5.72 – 24.1 |
The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16. Hurley stages: Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 15 | |
| Part B Izokibep 160 mg QW | 18 | |
| Part B Izokibep 160 mg Q2W | 14 |
The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W Then Izokibep QW/Q2W | 4 | |
| Part B Izokibep 160 mg QW | 5 | |
| Part B Izokibep 160 mg Q2W | 9 |
Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W (Up to Week 16) | 4 | |
| Part B Izokibep 160 mg Q2W (Up to Week 16) | 2 | |
| Part B Izokibep 160 mg QW (Up to Week 16) | 1 | |
| Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) | 1 | |
| Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) | 2 | |
| Part B: Izokibep 160 mg QW (Week 16 to 31) | 0 | |
| Part B: Izokibep 160 mg Q2W (Week 16 to 30) | 2 |
An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused sign
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W (Up to Week 16) | 40 | |
| Part B Izokibep 160 mg QW (Up to Week 16) | 49 | |
| Part B Izokibep 160 mg Q2W (Up to Week 16) | 48 | |
| Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) | 17 | |
| Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) | 16 | |
| Part B: Izokibep 160 mg QW (Week 16 to 31) | 27 | |
| Part B: Izokibep 160 mg Q2W (Week 16 to 30) | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Part B Placebo QW/Q2W (Up to Week 16) | 2 | |
| Part B Izokibep 160 mg QW (Up to Week 16) | 2 | |
| Part B Izokibep 160 mg Q2W (Up to Week 16) | 1 | |
| Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) | 2 | |
| Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) | 1 | |
| Part B: Izokibep 160 mg QW (Week 16 to 31) | 1 | |
| Part B: Izokibep 160 mg Q2W (Week 16 to 30) | 0 |
Time frame: Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Part A Izokibep 160 mg QW | Part B Placebo QW/Q2W (Up … | Part B Izokibep 160 mg QW … | Part B Izokibep 160 mg Q2W… | Part B Placebo/Izokibep 16… | Part B Placebo/Izokibep 16… | Part B: Izokibep 160 mg Q2… | Part B: Izokibep 160 mg QW… |
|---|---|---|---|---|---|---|---|---|---|
| Epstein-Barr virus infection | Infections and infestations | — | — | — | — | — | — | — | — |
| Scrotal abscess | Infections and infestations | — | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — | — |
| Wound infection staphylococcal | Infections and infestations | — | — | — | — | — | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Cutaneous vasculitis | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — |
| Drug-induced liver injury | Hepatobiliary disorders | — | — | — | — | — | — | — | — |
| Colonic abscess | Infections and infestations | — | — | — | — | — | — | — | — |
| Crohn's disease | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Still's disease | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — | — | — | — | — | — | — |
| Multiple sclerosis | Nervous system disorders | — | — | — | — | — | — | — | — |
| Reaction | System | Part A Izokibep 160 mg QW | Part B Placebo QW/Q2W (Up … | Part B Izokibep 160 mg QW … | Part B Izokibep 160 mg Q2W… | Part B Placebo/Izokibep 16… | Part B Placebo/Izokibep 16… | Part B: Izokibep 160 mg Q2… | Part B: Izokibep 160 mg QW… |
|---|---|---|---|---|---|---|---|---|---|
| Injection site erythema | General disorders | — | — | — | — | — | — | — | — |
| Injection site pruritus | General disorders | — | — | — | — | — | — | — | — |
| Injection site swelling | General disorders | — | — | — | — | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — | — | — | — | — |
| Injection site warmth | General disorders | — | — | — | — | — | — | — | — |
| Injection site reaction | General disorders | — | — | — | — | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Injection site pain | General disorders | — | — | — | — | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — | — | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — |
| Injection site induration | General disorders | — | — | — | — | — | — | — | — |
| COVID-19 | Infections and infestations | — | — | — | — | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — | — | — | — |
| Migraine | Nervous system disorders | — | — | — | — | — | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — | — |
Most-reported serious reactions: Epstein-Barr virus infection, Scrotal abscess, Sepsis, Wound infection staphylococcal, Arthritis, Cutaneous vasculitis, Drug-induced liver injury, Colonic abscess.
Data from ClinicalTrials.gov NCT05355805 adverse events section.
Izokibep is a potent and selective inhibitor of interleukin 17A (IL-17A) that is being developed for treatment of hidradenitis suppurativa (HS). This study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (SC) in adult subjects with moderate to severe HS.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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