A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

ClinicalTrials.gov processed this data on September 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified May 2024 by ACELYRIN Inc.

Sponsor

ACELYRIN Inc.

Information Provided by (Responsible Party)

ACELYRIN Inc.

Clinicaltrials.gov Identifier

NCT05905783
Other Study ID Numbers: 22107
First Submitted: June 7, 2023
First Posted: June 15, 2023
Last Update Posted: September 19, 2024
Last Verified: May 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Hidradenitis Suppurativa
  • Drug: Placebo
  • Drug: Izokibep

Study Design

Study TypeInterventional
Actual Enrollment258 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa
Study Start DateJune 22, 2023
Actual Primary Completion DateJuly 24, 2024
Anticipated Study Completion DateMay 2025

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Group 1
    • 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
    • Solution for injection
  • Drug: Izokibep
    • Group 2
      • Participants will receive izokibep QW from Day 1 to Week 51.
    • Drug: Izokibep

      Outcome Measures

      Primary Outcome Measures

      1. Percentage of Participants Achieving HiSCR75 [Week 12]

      Secondary Outcome Measures

      1. Percentage of Participants Achieving HiSCR90 [Week 12]
      2. Percentage of Participants Achieving HiSCR100 [Week 12]
      3. Percentage of Participants Achieving HiSCR50 [Week 12]
      4. Percentage of Participants That Experience ≥ 1 Disease Flare [Up to Week 12]
      5. Change in Dermatology Life Quality Index (DLQI) [Baseline to Week 12]
      6. Percentage of Participants With Baseline Hurley Stage II Who Achieve Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 [Baseline and Week 12]
      7. Percentage of Participants Achieving at Least 3-point Reduction From Baseline in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at its Worst Among Participants With Baseline NRS ≥ 4 [Baseline and Week 12]
      8. Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Day 1 to Follow-up (Week 59)]
      9. Number of Participants With Events of Interest [Screening (Day -28) to Follow-up (Week 59)]
      10. Number of Participant With Serious Adverse Events (SAEs) [Screening (Day -28) to Follow-up (Week 59)]
      11. Number of Participants With Clinically Significant Changes in Laboratory Values [Screening (Day -28) to Follow-up (Week 59)]
      12. Number of Participants With Clinically Significant Change in Vital Signs [Screening (Day -28) to Follow-up (Week 59)]

      Eligibility Criteria

      Ages Eligible for Study 18 Years and Older (Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers No
      Inclusion Criteria
      • 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
      • 18 years of age or older
      • 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
      Exclusion Criteria
      • 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)
      • Other protocol defined Inclusion/Exclusion criteria may apply

      Contacts and Locations

      Sponsors and Collaborators ACELYRIN Inc.
      Locations
      • Clinical Research Site | Birmingham, Alabama, United States, 35233
      • Clinical Research Site | Scottsdale, Arizona, United States, 85255
      • Clinical Research Site | Scottsdale, Arizona, United States, 85260
      • Clinical Research Site | Fayetteville, Arkansas, United States, 72703
      • Clinical Research Site | Encino, California, United States, 91436
      • Clinical Research Site | Fountain Valley, California, United States, 92708
      • Clinical Research Site | Fremont, California, United States, 94538
      • Clinical Research Site | Los Angeles, California, United States, 90045
      • Clinical Research Site | Santa Monica, California, United States, 90404
      • Clinical Research Site | Boca Raton, Florida, United States, 33486
      • Clinical Research Site | Brandon, Florida, United States, 33511
      • Clinical Research Site | Coral Gables, Florida, United States, 33134
      • Clinical Research Site | Hollywood, Florida, United States, 33021
      • Clinical Research Site | Tampa, Florida, United States, 33607
      • Clinical Research Site | Tampa, Florida, United States, 33613
      • Clinical Research Site | Atlanta, Georgia, United States, 30315
      • Clinical Research Site | Sandy Springs, Georgia, United States, 30328
      • Clinical Research Site | Savannah, Georgia, United States, 31419
      • Clinical Research Site | Springfield, Illinois, United States, 62702
      • Clinical Research Site | Indianapolis, Indiana, United States, 46250
      • Clinical Research Site | Plainfield, Indiana, United States, 46168
      • Clinical Research Site | Topeka, Kansas, United States, 66614
      • Clinical Research Site | Murray, Kentucky, United States, 42071
      • Clinical Research Site | Baton Rouge, Louisiana, United States, 70808
      • Clinical Research Site | Baton Rouge, Louisiana, United States, 70809
      • Clinical Research Site | New Orleans, Louisiana, United States, 70115
      • Clinical Research Site | Largo, Maryland, United States, 20774
      • Clinical Research Site | Boston, Massachusetts, United States, 02215
      • Clinical Research Site | Canton, Michigan, United States, 48187
      • Clinical Research Site | Troy, Michigan, United States, 48084
      • Clinical Research Site | Lebanon, New Hampshire, United States, 03766
      • Clinical Research Site | New York, New York, United States, 10128
      • Clinical Research Site | Charlotte, North Carolina, United States, 28277
      • Clinical Research Site | Boardman, Ohio, United States, 44512
      • Clinical Research Site | Mason, Ohio, United States, 45040
      • Clinical Research Site | Springfield, Ohio, United States, 45505
      • Clinical Research Site | Portland, Oregon, United States, 97223
      • Clinical Research Site | Hershey, Pennsylvania, United States, 17033
      • Clinical Research Site | Pittsburgh, Pennsylvania, United States, 15213
      • Clinical Research Site | Sugarloaf, Pennsylvania, United States, 18249
      • Clinical Research Site | Thompson's Station, Tennessee, United States, 37179
      • Clinical Research Site | Arlington, Texas, United States, 76011
      • Clinical Research Site | Frisco, Texas, United States, 75034
      • Clinical Research Site | Pflugerville, Texas, United States, 78660
      • Clinical Research Site | San Antonio, Texas, United States, 78218
      • Clinical Research Site | The Woodlands, Texas, United States, 77380
      • Clinical Research Site | Webster, Texas, United States, 77598
      • Clinical Research Site | Springville, Utah, United States, 84663
      • Clinical Research Site | West Jordan, Utah, United States, 84088
      • Clinical Research Site | Charlottesville, Virginia, United States, 22908
      • Clinical Research Site | Edmonton, Alberta, Canada, T6G1C3
      • Clinical Research Site | Edmonton, Alberta, Canada, T6H4J8
      • Clinical Research Site | Winnipeg, Manitoba, Canada, R3M3Z4
      • Clinical Research Site | North Bay, Ontario, Canada, P1B 3Z7
      • Clinical Research Site | Peterborough, Ontario, Canada, K9J5K2
      • Clinical Research Site | Toronto, Ontario, Canada, M2N3A6
      • Clinical Research Site | Toronto, Ontario, Canada, M4W2N4
      • Clinical Research Site | Toronto, Ontario, Canada, M5A3R6
      • Clinical Research Site | Waterloo, Ontario, Canada, N2J1C4
      • Clinical Research Site | Saskatoon, Saskatchewan, Canada, S7K2C1
      • Clinical Research Site | Dijon, Bourgogne-Franche-Comté, France, 21000
      • Clinical Research Site | Montpellier, Occitanie, France, 34090
      • Clinical Research Site | Nantes, Pays De La Loire, France, 44000
      • Clinical Research Site | Toulon, Provence-Alpes-Côte d'Azur, France, 83000
      • Clinical Research Site | Darmstadt, Hessen, Germany, 64283
      • Clinical Research Site | Bad Bentheim, Lower Saxony, Germany, 48455
      • Clinical Research Site | Mainz, Rhineland-Palatinate, Germany, 55128
      • Clinical Research Site | Leipzig, Saxony, Germany, 04103
      • Clinical Research Site | Kiel, Schleswig-Holstein, Germany, 24148
      • Clinical Research Site | Debrecen, Hajdú-Bihar, Hungary, 4032
      • Clinical Research Site | Zalaegerszeg, Zala, Hungary, 8900
      • Clinical Research Site | Budapest, Hungary, 1036
      • Clinical Research Site | Fukuoka, Fukoka Prefecture, Japan, 814-0180
      • Clinical Research Site | Kitakyushu, Fukuoka, Japan, 807-8555
      • Clinical Research Site | Obihiro, Hokkaido Prefecture, Japan, 080-0013
      • Clinical Research Site | Sapporo, Hokkaido Prefecture, Japan, 060-0063
      • Clinical Research Site | Kawasaki, Kanagawa Prefecture, Japan, 216-8511
      • Clinical Research Site | Yokohama, Kanagawa Prefecture, Japan, 236-0004
      • Clinical Research Site | Kyoto, Kyoto Prefecture, Japan, 602-8566
      • Clinical Research Site | Osaka, Osaka Prefecture, Japan, 589-8511
      • Clinical Research Site | Itabashi, Tokyo Prefecture, Japan, 173-8610
      • Clinical Research Site | Shinjuku-Ku, Tokyo Prefecture, Japan, 160-0023
      • Clinical Research Site | Nishinomiya, Japan, 663-8186
      • Clinical Research Site | Kraków, Lesser Poland Voivodeship, Poland, 30-001
      • Clinical Research Site | Kraków, Lesser Poland Voivodeship, Poland, 90-436
      • Clinical Research Site | Wrocław, Lower Silesian Voivodeship, Poland, 50-566
      • Clinical Research Site | Wrocław, Lower Silesian Voivodeship, Poland, 51-318
      • Clinical Research Site | Lublin, Lublin Voivodeship, Poland, 20-573
      • Clinical Research Site | Katowice, Silesian Voivodeship, Poland, 40-611
      • Clinical Research Site | Ożarowice, Silesian Voivodeship, Poland, 42-624
      • Clinical Research Site | Sosnowiec, Silesian Voivodeship, Poland, 41-218
      • Clinical Research Site | Łódź, Łódź Voivodeship, Poland, 90-265
      • Clinical Research Site | Sevilla, Andalusia, Spain, 41009
      • Clinical Research Site | Badalona, Catalonia, Spain, 08916
      • Clinical Research Site | Barcelona, Catalonia, Spain, 08041
      • Clinical Research Site | Palma De Mallorca, Illes Balears, Spain, 07120
      • Clinical Research Site | Manises, Valencia, Spain, 46940
      • Clinical Research Site | Madrid, Spain, 28031
      Investigators

        More Information

        Additional Relevant MeSH Terms

        • Hidradenitis Suppurativa
        • Hidradenitis
        • Sweat Gland Diseases
        • Skin Diseases
        • Skin Diseases, Bacterial
        • Bacterial Infections
        • Bacterial Infections and Mycoses
        • Infections
        • Skin Diseases, Infectious
        • Suppuration