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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503160-33-00 | Other Identifier | EU Clinical Trial Number |
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Per our 13Aug24 press release, we announced discontinuation of internal development in this indication. This decision was not due to safety reasons.
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Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive placebo as a subcutaneous (SC) injection every week (QW) from Day 1 to Week 15. Participants will then receive izokibep as a SC injection QW from Week 16 to Week 51. |
|
| Group 2 | Experimental | Participants will receive izokibep QW from Day 1 to Week 51. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Solution for injection |
| |
| Izokibep |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below:
HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving HiSCR90 at Week 12 | The percentage of participants achieving HiSCR90 was defined as meeting all 3 criteria below:
HiSCR90 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. |
Not provided
Inclusion Criteria:
General
Type of Participant and Disease Characteristics
Exclusion Criteria:
Medical Conditions
Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Shephard Mpofu | ACELYRIN Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Birmingham | Alabama | 35233 | United States | ||
| Clinical Research Site |
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A total of 258 participants were enrolled in Canada, France, Germany, Japan, Poland, Spain and the United States from June 2023 to January 2025. Participants were randomized to receive izokibep or placebo once weekly (QW) until Week 15 (Period 1). Then, all participants received izokibep QW from Week 16 until Week 51 (Period 2).
The Sponsor decided to terminate the study early after all participants completed (or discontinued) treatment at Week 32.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Izokibep 160 mg QW | Participants received placebo as a subcutaneous (SC) injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51. |
| FG001 | Izokibep 160 mg QW |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2024 | Jul 7, 2025 |
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| Drug |
Solution for injection |
|
| Week 12 |
| Percentage of Participants Achieving HiSCR100 at Week 12 | The percentage of participants achieving HiSCR100 was defined as meeting all 3 criteria below:
HiSCR100 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Week 12 |
| Percentage of Participants Achieving HiSCR50 at Week 12 | The percentage of participants achieving HiSCR50 was defined as meeting all 3 criteria below:
HiSCR50 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Week 12 |
| Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at 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:
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. | Up to Week 12 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | 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). | Baseline and Week 12 |
| Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at 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. | Week 12 |
| 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 | 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. | Week 12 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 | 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. | Up to Week 16 |
| Number of Participants With TEAEs, SAEs and AESIs in Period 2 | 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. | From Week 16 to follow-up, Week 59 |
| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Clinical Research Site | Scottsdale | Arizona | 85260 | United States |
| Clinical Research Site | Fayetteville | Arkansas | 72703 | United States |
| Clinical Research Site | Encino | California | 91436 | United States |
| Clinical Research Site | Fountain Valley | California | 92708 | United States |
| Clinical Research Site | Fremont | California | 94538 | United States |
| Clinical Research Site | Los Angeles | California | 90045 | United States |
| Clinical Research Site | Santa Monica | California | 90404 | United States |
| Clinical Research Site | Boca Raton | Florida | 33486 | United States |
| Clinical Research Site | Brandon | Florida | 33511 | United States |
| Clinical Research Site | Coral Gables | Florida | 33134 | United States |
| Clinical Research Site | Hollywood | Florida | 33021 | United States |
| Clinical Research Site | Tampa | Florida | 33607 | United States |
| Clinical Research Site | Tampa | Florida | 33613 | United States |
| Clinical Research Site | Atlanta | Georgia | 30315 | United States |
| Clinical Research Site | Sandy Springs | Georgia | 30328 | United States |
| Clinical Research Site | Savannah | Georgia | 31419 | United States |
| Clinical Research Site | Springfield | Illinois | 62702 | United States |
| Clinical Research Site | Indianapolis | Indiana | 46250 | United States |
| Clinical Research Site | Plainfield | Indiana | 46168 | United States |
| Clinical Research Site | Topeka | Kansas | 66614 | United States |
| Clinical Research Site | Murray | Kentucky | 42071 | United States |
| Clinical Research Site | Baton Rouge | Louisiana | 70808 | United States |
| Clinical Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Clinical Research Site | New Orleans | Louisiana | 70115 | United States |
| Clinical Research Site | Largo | Maryland | 20774 | United States |
| Clinical Research Site | Boston | Massachusetts | 02215 | United States |
| Clinical Research Site | Canton | Michigan | 48187 | United States |
| Clinical Research Site | Troy | Michigan | 48084 | United States |
| Clinical Research Site | Lebanon | New Hampshire | 03766 | United States |
| Clinical Research Site | New York | New York | 10128 | United States |
| Clinical Research Site | Charlotte | North Carolina | 28277 | United States |
| Clinical Research Site | Boardman | Ohio | 44512 | United States |
| Clinical Research Site | Mason | Ohio | 45040 | United States |
| Clinical Research Site | Springfield | Ohio | 45505 | United States |
| Clinical Research Site | Portland | Oregon | 97223 | United States |
| Clinical Research Site | Hershey | Pennsylvania | 17033 | United States |
| Clinical Research Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Research Site | Sugarloaf | Pennsylvania | 18249 | United States |
| Clinical Research Site | Thompson's Station | Tennessee | 37179 | United States |
| Clinical Research Site | Arlington | Texas | 76011 | United States |
| Clinical Research Site | Frisco | Texas | 75034 | United States |
| Clinical Research Site | Pflugerville | Texas | 78660 | United States |
| Clinical Research Site | San Antonio | Texas | 78218 | United States |
| Clinical Research Site | The Woodlands | Texas | 77380 | United States |
| Clinical Research Site | Webster | Texas | 77598 | United States |
| Clinical Research Site | Springville | Utah | 84663 | United States |
| Clinical Research Site | West Jordan | Utah | 84088 | United States |
| Clinical Research Site | Charlottesville | Virginia | 22908 | United States |
| Clinical Research Site | Edmonton | Alberta | T6G1C3 | Canada |
| Clinical Research Site | Edmonton | Alberta | T6H4J8 | Canada |
| Clinical Research Site | Winnipeg | Manitoba | R3M3Z4 | Canada |
| Clinical Research Site | North Bay | Ontario | P1B 3Z7 | Canada |
| Clinical Research Site | Peterborough | Ontario | K9J5K2 | Canada |
| Clinical Research Site | Toronto | Ontario | M2N3A6 | Canada |
| Clinical Research Site | Toronto | Ontario | M4W2N4 | Canada |
| Clinical Research Site | Toronto | Ontario | M5A3R6 | Canada |
| Clinical Research Site | Waterloo | Ontario | N2J1C4 | Canada |
| Clinical Research Site | Saskatoon | Saskatchewan | S7K2C1 | Canada |
| Clinical Research Site | Dijon | Bourgogne-Franche-Comté | 21000 | France |
| Clinical Research Site | Montpellier | Occitanie | 34090 | France |
| Clinical Research Site | Nantes | Pays de la Loire Region | 44000 | France |
| Clinical Research Site | Toulon | 83000 | France |
| Clinical Research Site | Darmstadt | Hesse | 64283 | Germany |
| Clinical Research Site | Bad Bentheim | Lower Saxony | 48455 | Germany |
| Clinical Research Site | Mainz | Rhineland-Palatinate | 55128 | Germany |
| Clinical Research Site | Leipzig | Saxony | 04103 | Germany |
| Clinical Research Site | Kiel | Schleswig-Holstein | 24148 | Germany |
| Clinical Research Site | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Clinical Research Site | Zalaegerszeg | Zala County | 8900 | Hungary |
| Clinical Research Site | Budapest | 1036 | Hungary |
| Clinical Research Site | Fukuoka | Fukoka Prefecture | 814-0180 | Japan |
| Clinical Research Site | Kitakyushu | Fukuoka | 807-8555 | Japan |
| Clinical Research Site | Obihiro | Hokkaido Prefecture | 080-0013 | Japan |
| Clinical Research Site | Sapporo | Hokkaido Prefecture | 060-0063 | Japan |
| Clinical Research Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Clinical Research Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Clinical Research Site | Kyoto | Kyoto | 602-8566 | Japan |
| Clinical Research Site | Osaka | Osaka | 589-8511 | Japan |
| Clinical Research Site | Shinjuku-Ku | Tokyo | 160-0023 | Japan |
| Clinical Research Site | tabashi City | Tokyo | 173-8610 | Japan |
| Clinical Research Site | Nishinomiya | 663-8186 | Japan |
| Clinical Research Site | Krakow | Lesser Poland Voivodeship | 30-001 | Poland |
| Clinical Research Site | Krakow | Lesser Poland Voivodeship | 90-436 | Poland |
| Clinical Research Site | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Clinical Research Site | Wroclaw | Lower Silesian Voivodeship | 51-318 | Poland |
| Clinical Research Site | Lublin | Lublin Voivodeship | 20-573 | Poland |
| Clinical Research Site | Katowice | Silesian Voivodeship | 40-611 | Poland |
| Clinical Research Site | Ożarowice | Silesian Voivodeship | 42-624 | Poland |
| Clinical Research Site | Sosnowiec | Silesian Voivodeship | 41-218 | Poland |
| Clinical Research Site | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Clinical Research Site | Seville | Andalusia | 41009 | Spain |
| Clinical Research Site | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Clinical Research Site | Badalona | Catalonia | 08916 | Spain |
| Clinical Research Site | Barcelona | Catalonia | 08041 | Spain |
| Clinical Research Site | Manises | Valencia | 46940 | Spain |
| Clinical Research Site | Madrid | 28031 | Spain |
Participants received izokibep as a SC injection QW from Day 1 to Week 51.
| Completed Period 1 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-Izokibep 160 mg QW | Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51. |
| BG001 | Izokibep 160 mg QW | Participants received izokibep QW from Day 1 to Week 51. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12 | The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below:
HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Full Analysis Set: all participants who were randomized. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving HiSCR90 at Week 12 | The percentage of participants achieving HiSCR90 was defined as meeting all 3 criteria below:
HiSCR90 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Full Analysis Set: all participants who were randomized. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving HiSCR100 at Week 12 | The percentage of participants achieving HiSCR100 was defined as meeting all 3 criteria below:
HiSCR100 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Full Analysis Set: all participants who were randomized. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Achieving HiSCR50 at Week 12 | The percentage of participants achieving HiSCR50 was defined as meeting all 3 criteria below:
HiSCR50 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods. | Full Analysis Set: all participants who were randomized. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at 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:
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. | Full Analysis Set: all participants who were randomized. | Posted | Mean | 95% Confidence Interval | percentage of participants | Up to Week 12 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) | 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). | Full Analysis Set: all participants who were randomized. Only participants with a result at the timepoint are included. | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline and Week 12 |
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| Secondary | Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at 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. | Full Analysis Set: all participants who were randomized. Participants with Hurley Stage II at baseline were included. | Posted | Mean | 95% Confidence Interval | percentage of participants | Week 12 |
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| 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 | 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. | Full Analysis Set: all participants who were randomized. Participants with baseline NRS ≥ 4 were included. | Posted | Mean | 95% Confidence Interval | Percentage of participants | Week 12 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 | 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. | Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment. | Posted | Count of Participants | Participants | Up to Week 16 |
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| Secondary | Number of Participants With TEAEs, SAEs and AESIs in Period 2 | 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. | 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. | Posted | Count of Participants | Participants | From Week 16 to follow-up, Week 59 |
|
From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks
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.
Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo QW - Izokibep 160 mg QW: Period 1 | Participants received placebo as a SC injection QW from Day 1 to Week 15. | 0 | 129 | 5 | 129 | 35 | 129 |
| EG001 | Izokibep 160 mg QW: Period 1 | Participants received izokibep QW from Day 1 to Week 15. | 0 | 129 | 1 | 129 | 93 | 129 |
| EG002 | Placebo QW - Izokibep 160 mg QW: Period 2 | Participants received izokibep as a SC injection QW from Week 16 to Week 51. | 0 | 109 | 3 | 109 | 69 | 109 |
| EG003 | Izokibep 160 mg QW: Period 2 | Participants received izokibep QW from Week 16 to Week 51. | 0 | 100 | 4 | 100 | 40 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (27.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (27.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Desk | Acelyrin Inc. | (650) 231 6625 | info@alumis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2024 | Jul 7, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Other |
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Participants received izokibep QW from Day 1 to Week 51. |
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Participants received izokibep QW from Day 1 to Week 51.
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