Trial · NCT05905783
Hidradenitis Suppurativa Study of Izokibep
NCT05905783, Phase 3, Terminated, ACELYRIN Inc.; results first posted 2025-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hidradenitis Suppurativa Study of Izokibep. Trials, record NCT05905783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05905783
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hidradenitis Suppurativa Study of Izokibep
- NCT number
- NCT05905783
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 258 participants, actual
- Lead sponsor
- ACELYRIN Inc.
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Placebo, Izokibep
- First posted
- 2023-06-15
- Last updated
- 2025-10-15
- Results first posted
- 2025-10-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | Week 12 | The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below: * (\[abscess and inflammatory nodule (AN) count at baseline - AN count at current visit\] / AN count at baseline) × 100% ≥ 75% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Percentage of Participants Achieving HiSCR90 at Week 12 | Week 12 | The percentage of participants achieving HiSCR90 was defined as meeting all 3 criteria below: * (\[AN count at baseline - AN count at current visit\] / AN count at baseline) × 100% ≥ 90% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR90 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Percentage of Participants Achieving HiSCR100 at Week 12 | Week 12 | The percentage of participants achieving HiSCR100 was defined as meeting all 3 criteria below: * (\[AN count at baseline - AN count at current visit\] / AN count at baseline) × 100% = 100% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR100 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Percentage of Participants Achieving HiSCR50 at Week 12 | Week 12 | The percentage of participants achieving HiSCR50 was defined as meeting all 3 criteria below: * \[(AN count at baseline - AN count at current visit) / AN count at baseline\] × 100% ≥ 50% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR50 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12 | Up to Week 12 | HS flares were defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline, i.e. participants must meet all the following criteria: * (AN count at current visit- AN count at baseline) / AN count at baseline ×100% ≥ 25% * AN count at current visit- AN count at baseline ≥ 2. Participants who received antibiotic therapy that could affect HS were imputed as non-response (NRI). Other participants with missing data were imputed with multiple imputation. |
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline and Week 12 | DLQI included 10 items arranged in 6 categories: symptoms and feelings, daily activity, leisure, work or study, interpersonal relationships, and treatment. The total score could range from 0 (no impact to life quality) to 30 (maximum impact). |
| Secondary | Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at Week 12 | Week 12 | Calculated as observed values of 0, 1, or 2 for AN count (abscess count + inflammatory nodule count). AN count of 0, 1, or 2 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Percentage of Participants With Baseline NRS ≥ 4 Achieving at Least 3-point Reduction at Week 12 in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at Its Worst | Week 12 | NRS in Patient Global Assessment of Skin Pain ranged from 0 (no skin pain) to 10 (skin pain bad as you can imagine). The skin pain score at each visit was calculated using average of daily scores among the 7 days up to and including the day of visit, with a minimum of 4 days (consecutive or non-consecutive) with scores required. Reduction in NRS was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 | Up to Week 16 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. The following events of special interest were monitored in this study: candida infection; inflammatory bowel disease (IBD); suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions. Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs. |
| Secondary | Number of Participants With TEAEs, SAEs and AESIs in Period 2 | From Week 16 to follow-up, Week 59 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. The following events of special interest were monitored in this study: candida infection; IBD; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions. Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | Week 12 | Full Analysis Set: all participants who were randomized. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants Achieving HiSCR90 at Week 12 | Week 12 | Full Analysis Set: all participants who were randomized. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants Achieving HiSCR100 at Week 12 | Week 12 | Full Analysis Set: all participants who were randomized. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants Achieving HiSCR50 at Week 12 | Week 12 | Full Analysis Set: all participants who were randomized. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12 | Up to Week 12 | Full Analysis Set: all participants who were randomized. | percentage of participants | MEAN |
| SECONDARY | Change From Baseline in Dermatology Life Quality Index (DLQI) | Baseline and Week 12 | Full Analysis Set: all participants who were randomized. Only participants with a result at the timepoint are included. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at Week 12 | Week 12 | Full Analysis Set: all participants who were randomized. Participants with Hurley Stage II at baseline were included. | percentage of participants | MEAN |
| SECONDARY | Percentage of Participants With Baseline NRS ≥ 4 Achieving at Least 3-point Reduction at Week 12 in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at Its Worst | Week 12 | Full Analysis Set: all participants who were randomized. Participants with baseline NRS ≥ 4 were included. | Percentage of participants | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 | Up to Week 16 | Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs, SAEs and AESIs in Period 2 | From Week 16 to follow-up, Week 59 | Safety Analysis Set Period 2: All participants who were randomized and received at least 1 administration of study treatment in Period 2 of the Study. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | Placebo-Izokibep 160 mg QW | 20.3 | 95% Confidence Interval 13.1 to 27.6 | percentage of participants | |
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | Izokibep 160 mg QW | 32.6 | 95% Confidence Interval 24.3 to 40.9 | percentage of participants | |
| Percentage of Participants Achieving HiSCR90 at Week 12 | Placebo-Izokibep 160 mg QW | 9.2 | 95% Confidence Interval 3.8 to 14.5 | percentage of participants | |
| Percentage of Participants Achieving HiSCR90 at Week 12 | Izokibep 160 mg QW | 24.3 | 95% Confidence Interval 16.7 to 31.9 | percentage of participants | |
| Percentage of Participants Achieving HiSCR100 at Week 12 | Placebo-Izokibep 160 mg QW | 7.3 | 95% Confidence Interval 2.5 to 12.2 | percentage of participants | |
| Percentage of Participants Achieving HiSCR100 at Week 12 | Izokibep 160 mg QW | 21.4 | 95% Confidence Interval 14.2 to 28.7 | percentage of participants | |
| Percentage of Participants Achieving HiSCR50 at Week 12 | Placebo-Izokibep 160 mg QW | 36.5 | 95% Confidence Interval 27.8 to 45.2 | percentage of participants | |
| Percentage of Participants Achieving HiSCR50 at Week 12 | Izokibep 160 mg QW | 47.9 | 95% Confidence Interval 39.0 to 56.8 | percentage of participants | |
| Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12 | Placebo-Izokibep 160 mg QW | 31.1 | 95% Confidence Interval 22.9 to 39.3 | percentage of participants | |
| Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12 | Izokibep 160 mg QW | 28.3 | 95% Confidence Interval 20.5 to 36.2 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo-Izokibep 160 mg QW | 129 | |
| Overall Study | STARTED | Izokibep 160 mg QW | 129 | |
| Overall Study | Completed Period 1 | Placebo-Izokibep 160 mg QW | 109 | |
| Overall Study | Completed Period 1 | Izokibep 160 mg QW | 103 | |
| Overall Study | COMPLETED | Placebo-Izokibep 160 mg QW | 19 | |
| Overall Study | COMPLETED | Izokibep 160 mg QW | 9 | |
| Overall Study | NOT COMPLETED | Placebo-Izokibep 160 mg QW | 110 | |
| Overall Study | NOT COMPLETED | Izokibep 160 mg QW | 120 |
Source ClinicalTrials.gov
Adverse events76
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | General disorders | Placebo QW - Izokibep 160 mg QW: Period 1 | 10 | 129 | 16 |
| other | Injection site reaction | General disorders | Izokibep 160 mg QW: Period 1 | 86 | 129 | 380 |
| other | Injection site reaction | General disorders | Placebo QW - Izokibep 160 mg QW: Period 2 | 66 | 109 | 328 |
| other | Injection site reaction | General disorders | Izokibep 160 mg QW: Period 2 | 34 | 100 | 186 |
| other | Fatigue | General disorders | Placebo QW - Izokibep 160 mg QW: Period 1 | 3 | 129 | 3 |
| other | Fatigue | General disorders | Izokibep 160 mg QW: Period 1 | 7 | 129 | 12 |
| other | Fatigue | General disorders | Placebo QW - Izokibep 160 mg QW: Period 2 | 0 | 109 | 0 |
| other | Fatigue | General disorders | Izokibep 160 mg QW: Period 2 | 2 | 100 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo QW - Izokibep 160 mg QW: Period 1 | 9 | 129 | 12 |
| other | Nasopharyngitis | Infections and infestations | Izokibep 160 mg QW: Period 1 | 11 | 129 | 11 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo QW - Izokibep 160 mg QW: Period 1 | 0 | 129 |
| Total, all-cause mortality | Izokibep 160 mg QW: Period 1 | 0 | 129 |
| Total, all-cause mortality | Placebo QW - Izokibep 160 mg QW: Period 2 | 0 | 109 |
| Total, all-cause mortality | Izokibep 160 mg QW: Period 2 | 0 | 100 |
| Total, other adverse events | Placebo QW - Izokibep 160 mg QW: Period 1 | 35 | 129 |
| Total, other adverse events | Izokibep 160 mg QW: Period 1 | 93 | 129 |
| Total, other adverse events | Placebo QW - Izokibep 160 mg QW: Period 2 | 69 | 109 |
| Total, other adverse events | Izokibep 160 mg QW: Period 2 | 40 | 100 |
| Total, serious adverse events | Placebo QW - Izokibep 160 mg QW: Period 1 | 5 | 129 |
| Total, serious adverse events | Izokibep 160 mg QW: Period 1 | 1 | 129 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05905783
GET https://conductscience.org/api/trials/v1/NCT05905783/results?page=2