Hidradenitis Suppurativa Study of Izokibep

NCT05905783 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: 221072022-503160-33-00
• Study Type: interventional
• Target: 258
• Locations: 8 countries
• Sites: 98

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• 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: * (\[abscess and inflammatory nodule (AN) count at baseline - AN count at current visit\] / 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.

  Week 12

Secondary Outcomes (9)

• Percentage of Participants Achieving HiSCR90 at Week 12

  Week 12

• Percentage of Participants Achieving HiSCR100 at Week 12

  Week 12

• Percentage of Participants Achieving HiSCR50 at Week 12

  Week 12

• Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12

  Up to Week 12

• Change From Baseline in Dermatology Life Quality Index (DLQI)

  Baseline and Week 12

Study Arms (2)

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.

Drug: Placebo; Drug: Izokibep

Group 2

EXPERIMENTAL

Participants will receive izokibep QW from Day 1 to Week 51.

Drug: Izokibep

Interventions

Placebo DRUG

Solution for injection

Group 1

Izokibep DRUG

Solution for injection

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General
• Participant has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in protocol
• years of age or older
• No known history of active tuberculosis unless adequately treated according to World Health Organization/Center for Disease Control and Prevention therapeutic guidance and determined to be fully recovered by a tuberculosis specialist
• Type of Participant and Disease Characteristics
• Diagnosis of HS for ≥ 6 months prior to first dose of study drug
• Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or Hurley Stage III
• A total AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization
• Participant must have had an inadequate response to oral antibiotics OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS
• Must agree to use daily or a minimum of 3 days a week over-the-counter topical antiseptics
• Participant must be willing to complete a daily skin pain diary

You may not qualify if:

• Medical Conditions
• Draining fistula count of \> 20
• Outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization
• Other active skin disease or condition that could interfere with study assessments
• History of active inflammatory bowel disease (IBD) OR symptoms within the last year that may be suggestive of IBD
• Chronic pain not associated with HS
• Uncontrolled, clinically significant system disease
• History of demyelinating disease or neurological symptoms suggestive of demyelinating disease
• Malignancy within 5 years
• The participant is at risk of self-harm or harm to others
• Active infection or history of certain infections
• Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved)
• Known history of human immunodeficiency virus (HIV)

Sponsors & Collaborators

• ACELYRIN Inc.: lead

Study Sites (98)

Clinical Research Site

Birmingham, Alabama, 35233, United States

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Scottsdale, Arizona, 85255, United States

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Scottsdale, Arizona, 85260, United States

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Fayetteville, Arkansas, 72703, United States

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Encino, California, 91436, United States

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Fountain Valley, California, 92708, United States

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Fremont, California, 94538, United States

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Los Angeles, California, 90045, United States

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Santa Monica, California, 90404, United States

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Boca Raton, Florida, 33486, United States

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Brandon, Florida, 33511, United States

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Coral Gables, Florida, 33134, United States

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Hollywood, Florida, 33021, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Atlanta, Georgia, 30315, United States

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Sandy Springs, Georgia, 30328, United States

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Savannah, Georgia, 31419, United States

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Springfield, Illinois, 62702, United States

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Indianapolis, Indiana, 46250, United States

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Plainfield, Indiana, 46168, United States

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Topeka, Kansas, 66614, United States

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Murray, Kentucky, 42071, United States

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Baton Rouge, Louisiana, 70808, United States

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Baton Rouge, Louisiana, 70809, United States

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New Orleans, Louisiana, 70115, United States

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Largo, Maryland, 20774, United States

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Boston, Massachusetts, 02215, United States

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Canton, Michigan, 48187, United States

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Troy, Michigan, 48084, United States

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Lebanon, New Hampshire, 03766, United States

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New York, New York, 10128, United States

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Charlotte, North Carolina, 28277, United States

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Boardman, Ohio, 44512, United States

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Mason, Ohio, 45040, United States

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Springfield, Ohio, 45505, United States

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Portland, Oregon, 97223, United States

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Hershey, Pennsylvania, 17033, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sugarloaf, Pennsylvania, 18249, United States

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Thompson's Station, Tennessee, 37179, United States

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Arlington, Texas, 76011, United States

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Frisco, Texas, 75034, United States

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Pflugerville, Texas, 78660, United States

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San Antonio, Texas, 78218, United States

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The Woodlands, Texas, 77380, United States

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Webster, Texas, 77598, United States

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Springville, Utah, 84663, United States

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West Jordan, Utah, 84088, United States

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Charlottesville, Virginia, 22908, United States

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Edmonton, Alberta, T6G1C3, Canada

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Edmonton, Alberta, T6H4J8, Canada

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Winnipeg, Manitoba, R3M3Z4, Canada

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North Bay, Ontario, P1B 3Z7, Canada

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Peterborough, Ontario, K9J5K2, Canada

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Toronto, Ontario, M2N3A6, Canada

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Toronto, Ontario, M4W2N4, Canada

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Toronto, Ontario, M5A3R6, Canada

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Waterloo, Ontario, N2J1C4, Canada

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Saskatoon, Saskatchewan, S7K2C1, Canada

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Dijon, Bourgogne-Franche-Comté, 21000, France

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Montpellier, Occitanie, 34090, France

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Nantes, Pays de la Loire Region, 44000, France

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Toulon, 83000, France

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Darmstadt, Hesse, 64283, Germany

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Bad Bentheim, Lower Saxony, 48455, Germany

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Mainz, Rhineland-Palatinate, 55128, Germany

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Leipzig, Saxony, 04103, Germany

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Kiel, Schleswig-Holstein, 24148, Germany

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Debrecen, Hajdú-Bihar, 4032, Hungary

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Zalaegerszeg, Zala County, 8900, Hungary

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Budapest, 1036, Hungary

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Fukuoka, Fukoka Prefecture, 814-0180, Japan

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Kitakyushu, Fukuoka, 807-8555, Japan

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Obihiro, Hokkaido Prefecture, 080-0013, Japan

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Sapporo, Hokkaido Prefecture, 060-0063, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Yokohama, Kanagawa, 236-0004, Japan

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Kyoto, Kyoto, 602-8566, Japan

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Osaka, Osaka, 589-8511, Japan

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Shinjuku-Ku, Tokyo, 160-0023, Japan

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tabashi City, Tokyo, 173-8610, Japan

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Nishinomiya, 663-8186, Japan

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Krakow, Lesser Poland Voivodeship, 30-001, Poland

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Krakow, Lesser Poland Voivodeship, 90-436, Poland

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Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

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Wroclaw, Lower Silesian Voivodeship, 51-318, Poland

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Lublin, Lublin Voivodeship, 20-573, Poland

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Katowice, Silesian Voivodeship, 40-611, Poland

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Ożarowice, Silesian Voivodeship, 42-624, Poland

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Sosnowiec, Silesian Voivodeship, 41-218, Poland

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Lodz, Łódź Voivodeship, 90-265, Poland

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Seville, Andalusia, 41009, Spain

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Palma de Mallorca, Balearic Islands, 07120, Spain

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Badalona, Catalonia, 08916, Spain

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Barcelona, Catalonia, 08041, Spain

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Manises, Valencia, 46940, Spain

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Madrid, 28031, Spain

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MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Clinical Trials Information Desk
• Organization: Acelyrin Inc.

info@alumis.com

(650) 231 6625

Study Officials

• Shephard Mpofu

  ACELYRIN Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: June 22, 2023
• Primary Completion: July 24, 2024
• Study Completion: January 27, 2025
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2024-12

Locations

DE (5); CA (10); US (50); FR (4); ES (6); PL (9); JP (11); HU (3)