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Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Primary Purpose

Hidradenitis Suppurativa

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Izokibep

Placebo to izokibep

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring hidradenitis suppurativa, Izokibep

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
18 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 ≥ 3 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.

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.
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).

Other protocol defined Inclusion/Exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Part A (Open-label) izokibep every week

Part B (Double-blind) izokibep every week

Part B (Double-blind) izokibep every other week

Part B (Double-blind) placebo every week

Part B (Double-blind) placebo every other week

Arm Description

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

Participants will receive izokibep weekly for 31 weeks.

Participants will receive izokibep every other week for 30 weeks.

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

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

Outcomes

Primary Outcome Measures

Part A: Hidradenitis suppurativa clinical response (HiSCR75)

Part B: Hidradenitis suppurativa clinical response (HiSCR75)

Secondary Outcome Measures

Part A: Incidence of treatment-emergent adverse events (TEAEs)

Part A: Incidence of serious adverse events (SAEs)

Part A: Incidence of clinically significant changes in laboratory values

Part A: Incidence of clinically significant changes in vital signs

Part A: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint

In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay.

Part B: Percent of subjects achieving HiSCR90

Part B: Percent of subjects achieving HiSCR100

Part B: Percent of subjects achieving HiSCR50

Part B: Percentage of subjects who experience ≥ 1 disease flare through 16 weeks of treatment

Part B: Percent of subjects with Hurley Stage II at baseline who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2

Part B: Percentage of subjects achieving at least 3 point reduction from baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at its worst at Week 16 among participants with baseline NRS ≥ 4

Part B: Incidence of treatment-emergent adverse events (TEAEs)

Part B: Incidence of events of interest

Part B: Incidence of serious adverse events (SAEs)

Part B: Incidence of clinically significant changes in laboratory values

Part B: Incidence of clinically significant changes in vital signs

Part B: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint

In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay.

Full Information

NCT ID

NCT05355805

First Posted

April 12, 2022

Last Updated

July 25, 2023

Sponsor

ACELYRIN Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05355805

Brief Title

Hidradenitis Suppurativa Phase 2b Pivotal Study of Izokibep

Official Title

A Phase 2b Pivotal Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 5, 2022 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ACELYRIN Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hidradenitis Suppurativa

Keywords

hidradenitis suppurativa, Izokibep

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A (Open-label) izokibep every week

Arm Type

Experimental

Arm Description

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

Arm Title

Part B (Double-blind) izokibep every week

Arm Type

Experimental

Arm Description

Participants will receive izokibep weekly for 31 weeks.

Arm Title

Part B (Double-blind) izokibep every other week

Arm Type

Experimental

Arm Description

Participants will receive izokibep every other week for 30 weeks.

Arm Title

Part B (Double-blind) placebo every week

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Part B (Double-blind) placebo every other week

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Izokibep

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo to izokibep

Intervention Description

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

Primary Outcome Measure Information:

Title

Part A: Hidradenitis suppurativa clinical response (HiSCR75)

Time Frame

Part A: Week 12

Title

Part B: Hidradenitis suppurativa clinical response (HiSCR75)

Time Frame

Part B: Week 16

Secondary Outcome Measure Information:

Title

Part A: Incidence of treatment-emergent adverse events (TEAEs)

Time Frame

Part A: Screening (Day -28) to Follow-up Week 39

Title

Part A: Incidence of serious adverse events (SAEs)

Time Frame

Part A: Screening (Day -28) to Follow-up Week 39

Title

Part A: Incidence of clinically significant changes in laboratory values

Time Frame

Part A: Screening (Day -28) to Follow-up Week 39

Title

Part A: Incidence of clinically significant changes in vital signs

Time Frame

Part A: Screening (Day -28) to Follow-up Week 39

Title

Part A: Laboratory data confirming presence of anti-drug antibodies at each planned collection timepoint

Description

In patients treated with izokibep: the detection and characterization of antibodies to izokibep will be performed via assay.

Time Frame

Part A: Day 1, Weeks 4, 8, 12, 16, 24, 32 and at follow-up (Weeks 39 and 45)

Title

Part B: Percent of subjects achieving HiSCR90

Time Frame

Part B: Week 16

Title

Part B: Percent of subjects achieving HiSCR100

Time Frame

Part B: Week 16

Title

Part B: Percent of subjects achieving HiSCR50

Time Frame

Part B: Week 16

Title

Part B: Percentage of subjects who experience ≥ 1 disease flare through 16 weeks of treatment

Time Frame

Part B: Day 1 through to Week 16

Title

Part B: Percent of subjects with Hurley Stage II at baseline who achieve Abscess and Inflammatory Nodule (AN) count of 0, 1, or 2

Time Frame

Part B: Week 16

Title

Time Frame

Part B: Week 16

Title

Part B: Incidence of treatment-emergent adverse events (TEAEs)

Time Frame