Hidradenitis Suppurativa Phase 2b Study of Izokibep

NCT05355805 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 211022021-005713-13
• Study Type: interventional
• Target: 205
• Locations: 6 countries
• Sites: 44

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa; Izokibep

Outcome Measures

Primary Outcomes (2)

• Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 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.

  Part A: Baseline to Week 12

• Part B: Number of Participants Who Achieved HiSCR75 at Week 16

  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.

  Part B: Baseline to Week 16

Secondary Outcomes (11)

• Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

• Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs)

  Baseline, Week 16, Week 32, Week 39

• Part B: Number of Participants Who Achieved HiSCR90 at Week 16

  Part B: Baseline to Week 16

• Part B: Number of Participants Who Achieved HiSCR100 at Week 16

  Part B: Baseline to Week 16

• Part B: Number of Participants Who Achieved HiSCR50 at Week 16

  Part B: Baseline to Week 16

Study Arms (5)

Part A (Open-label) izokibep every week

EXPERIMENTAL

Participants will receive izokibep every week from Day 1 through Week 31

Drug: Izokibep

Part B (Double-blind) izokibep every week

EXPERIMENTAL

Participants will receive izokibep every week for 31 weeks.

Drug: Izokibep

Part B (Double-blind) izokibep every other week

EXPERIMENTAL

Participants will receive izokibep every other week for 30 weeks.

Drug: Izokibep

Part B (Double-blind) placebo every week

PLACEBO COMPARATOR

Participants will receive placebo every week up to Week 15, then izokibep from Week 16 to Week 31.

Drug: Placebo to izokibep

Part B (Double-blind) placebo every other week

PLACEBO COMPARATOR

Participants will receive placebo every other week up to Week 14, then izokibep from Week 16 to Week 30.

Drug: Placebo to izokibep

Interventions

Izokibep DRUG

Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)

Part A (Open-label) izokibep every week; Part B (Double-blind) izokibep every other week; Part B (Double-blind) izokibep every week

Placebo to izokibep DRUG

Form: Solution for injection Route of administration: Subcutaneous (SC)

Part B (Double-blind) placebo every other week; Part B (Double-blind) placebo every week

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General
• Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• years to 75 years of age
• Type of Subject and Disease Characteristics
• Diagnosis of hidradenitis suppurativa (HS) for ≥ 1 year prior to first dose of study drug.
• Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is Hurley Stage II or III.
• A total abscess and inflammatory nodule (AN) count of ≥ 5 at screening and Day 1 prior to enrollment/randomization.
• Subject 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 over-the-counter topical antiseptics.
• Subject must be willing to complete a daily skin pain diary for at least 3 days prior to Day 1 visit.

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.
• 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 subject 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 ≤ 3 months of screening 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 (44)

Clinical Research Site

Birmingham, Alabama, 35233-3110, United States

Location

Clinical Research Site

Encino, California, 91436-2428, United States

Location

Clinical Research Site

Fountain Valley, California, 92708-3701, United States

Location

Clinical Research Site

Los Angeles, California, 90033, United States

Location

Clinical Research Site

Los Angeles, California, 90045-3606, United States

Location

Clinical Research Site

Ocala, Florida, 34470, United States

Location

Clinical Research Site

Tampa, Florida, 33624-2038, United States

Location

Clinical Research Site

Sandy Springs, Georgia, 30328, United States

Location

Clinical Research Site

Savannah, Georgia, 31406, United States

Location

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Rolling Meadows, Illinois, 60008-3811, United States

Location

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Indianapolis, Indiana, 46250, United States

Location

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Plainfield, Indiana, 46168, United States

Location

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Murray, Kentucky, 42071-2515, United States

Location

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Baton Rouge, Louisiana, 70808, United States

Location

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New York, New York, 10028-3001, United States

Location

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Mason, Ohio, 45040-4520, United States

Location

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Portland, Oregon, 97223, United States

Location

Clinical Research Site

Philadelphia, Pennsylvania, 19103-4708, United States

Location

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Pittsburgh, Pennsylvania, 15213-3403, United States

Location

Clinical Research Site

Webster, Texas, 77598, United States

Location

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London, Ontario, N6A 2C2, Canada

Location

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Markham, Ontario, L3P 1X2, Canada

Location

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Waterloo, Ontario, N2J 1C4, Canada

Location

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Québec, Quebec, G1N 4V3, Canada

Location

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Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

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Bad Bentheim, Lower Saxony, 48455, Germany

Location

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Bochum, Northwest, 44791, Germany

Location

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Kiel, Schleswig-Holstein, 24105, Germany

Location

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Kiel, Schleswig-Holstein, 24148, Germany

Location

Clinical Research Site

Schwerin, 19055, Germany

Location

Clinical Research Site

Budapest, BU, 1036, Hungary

Location

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Debrecen, HB, 4032, Hungary

Location

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Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

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Krakow, Lesser Poland Voivodeship, 31-147, Poland

Location

Clinical Research Site

Wroclaw, Lower Silesian Voivodeship, 50-566, Poland

Location

Clinical Research Site

Wroclaw, Lower Silesian Voivodeship, 51-318, Poland

Location

Clinical Research Site

Bialystok, Podlaskie Voivodeship, 15-453, Poland

Location

Clinical Research Site

Katowice, Silesian Voivodeship, 40-615, Poland

Location

Clinical Research Site

Lublin, 20-573, Poland

Location

Clinical Research Site

Szczecin, 70-332, Poland

Location

Clinical Research Site

Palma de Mallorca, PM, 07120, Spain

Location

Clinical Research Site

Pontevedra, PO, 36001, Spain

Location

Clinical Research Site

Manises, V, 46940, Spain

Location

Clinical Research Site

Barcelona, 8036, Spain

Location

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: Donald Betah
• Organization: Acelyrin

Donald.Betah@acelyrin.com

(805) 419-3805

Study Officials

• Donald Betah, MD

  ACELYRIN Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 2, 2022
• Study Start: May 5, 2022
• Primary Completion: August 2, 2023
• Study Completion: February 21, 2024
• Last Updated: June 3, 2025
• Results First Posted: September 25, 2024

Record last verified: 2025-03

Locations

DE (5); ES (4); PL (8); CA (5); US (20); HU (2)