Hidradenitis Suppurativa Phase 3 Study of Izokibep

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Acelyrin Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

15 Dec 2023 → 28 Jan 2025

Decision date (initial)

2023-11-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-503160-33-00

ClinicalTrials.gov

NCT05905783

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate the efficacy of izokibep compared with placebo, as measured by percentage of subjects achieving HiSCR75 at Week 12

Secondary objectives 1

1. To demonstrate that izokibep is efficacious compared with placebo as measured by: • Percentage of subjects achieving HiSCR90 at Week 12 • Percentage of subjects achieving HiSCR100 at Week 12 • Percentage of subjects achieving HiSCR50 at Week 12 • Percentage of subjects who experience ≥ 1 disease flare through 12 weeks of treatment • Dermatology Life Quality Index (DLQI) • Percentage of subjects with baseline Hurley Stage II who achieve AN count of 0, 1, or 2 at Week 12 • Percentage of subjects achieving at least 3 point reduction from baseline in NRS Patient Global Assessment of Skin Pain at its worst among subjects with baseline NRS ≥ 4 To assess the safety and tolerability of izokibep as measured by the incidence of TEAEs, events of interest, SAEs, and clinically significant laboratory values and vital signs

Conditions and MedDRA coding

Hidradenitis Suppurativa

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 2. Subject must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age and above, at the time of signing the informed consent. 4. Hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguino-crural fold), one of which is Hurley Stage II or Hurley Stage III at screening and Day 1 prior to enrollment/randomization. 5. A total AN count of ≥ 5 at screening and Day 1 prior to enrollment/randomization. 6. Subject must have had an inadequate response to oral antibiotics (defined as ≥ 3-month treatment with an oral antibiotic for treatment of HS) OR exhibited recurrence after discontinuation to, OR demonstrated intolerance to, OR have a contraindication to oral antibiotics for treatment of their HS as assessed by the investigator through subject interview and review of medical history. 10. Subject has a negative TB test at screening

Exclusion criteria 1

1. Other active skin disease or condition (eg, bacterial, fungal or viral infection) that could interfere with study assessments. 4. History of active IBD OR Any of the following symptoms (of unknown etiology) or any signs or symptoms within the last year that in the opinion of the investigator may be suggestive of IBD, with fecal calprotectin > 500 μg/g; OR if fecal calprotectin > 150 to < 500 μg/g without confirmed approval from a gastroenterology consultation that an IBD diagnosis is clinically unlikely (see Section 8.2.10) when the following clinical signs and symptoms are present: a. prolonged or recurrent diarrhea b. prolonged or recurrent abdominal pain c. blood in stool 9. Risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessed at screening. Subjects with major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication. If on medication for major depressive disorder, subjects must have been on a stable antidepressant dose for at least 3 months prior to the first dose of study drug and agree to continue for the duration of the study or as indicated by their treating psychiatrist. 10. History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. 11. Active infection or history of infection as follows: a. Any active infection for which oral antiinfectives (antibiotics, antivirals, antifungals) were used ≤ 14 days prior to first dose of study drug (except for the use of a stable dose allowable antibiotics [doxycycline or minocycline only] for HS). b. A serious infection requiring hospitalization or IV anti-infectives (antibiotics, antivirals, antifungals) ≤ 30 days prior to first dose of study drug. c. Recurrent or chronic infections or other active infections that in the opinion of the investigator might cause this study to be detrimental to the subject. 12. Candida infection requiring systemic treatment within 3 months prior to first dose of study drug. 13. Tuberculosis or fungal infection seen on available chest xray taken within 3 months prior to screening (Exception: documented evidence of completed treatment and clinical resolution). 15. Previous exposure to izokibep or any other IL-17 inhibitor and IL-17 receptor inhibitors (eg, secukinumab, ixekizumab, bimekizumab, brodalumab).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. HiSCR75 at Week 12

Secondary endpoints 1

1. HiSCR90 at Week 12 • HiSCR100 at Week 12 • HiSCR50 at Week 12• HS flares through Week 12 • Change in DLQI from baseline to Week 12 • AN count of 0, 1, or 2 at Week 12 • Change from baseline in NRS in Patient Global Assessment of Skin Pain at its worst at Week 12 • TEAEs and SAEs • Laboratory values and vital signs at collected timepoints

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Acelyrin Inc.

Sponsor organisation

Acelyrin Inc.

Address

23371 Mulholland Drive

City

Woodland Hills

Postcode

91364-2734

Country

United States

Scientific contact point

Organisation

Acelyrin Inc.

Contact name

Clinical Trials Information Desk

Public contact point

Organisation

Acelyrin Inc.

Contact name

Clinical Trials Information Desk

Third parties 5

Locations

5 EU/EEA countries · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications