A Study to Assess Subcutaneous Lirentelimab (AK002) in Chronic Spontaneous Urticaria

NCT05528861 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: AK002-027
• Study Type: interventional
• Target: 127
• Locations: 3 countries
• Sites: 67

Brief Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.

Conditions

Chronic Spontaneous Urticaria

Keywords

Chronic Spontaneous Urticaria; Chronic Urticaria; Urticaria; Chronic Idiopathic Urticaria; Chronic Autoimmune Urticaria; Idiopathic Chronic Urticaria; Autoimmune Urticaria

Outcome Measures

Primary Outcomes (1)

• Absolute Change in Weekly Urticaria Assessment Score (UAS7) From Baseline at Week 12

  The UAS7 is the sum for 7 days of the daily Hives Severity Score (HSS) and the daily Itch Severity Score (ISS). The daily HSS is recorded on a scale of 0 (none) to 3 (\>50 hives) and the daily ISS is recorded on a scale of 0 (none) to 3 (severe). Therefore, the possible range of the weekly UAS7 score is 0-42, with 42 being the most severe.

  Baseline to Week 12

Secondary Outcomes (3)

• Absolute Change in Hives Severity Score (HSS7) From Baseline at Week 12

  Baseline to Week 12

• Absolute Change in Itch Severity Score (ISS7) From Baseline at Week 12

  Baseline to Week 12

• Proportion of Subjects Achieving Weekly Urticaria Assessment Score (UAS7)=0 at Week 12

  At Week 12

Other Outcomes (1)

• Safety and Tolerability of up to 6 Doses of Open-label AK002 in Subjects With Chronic Spontaneous Urticaria in the Open-label Extension Period

  Through study completion, up to 34 weeks (open-label extension period)

Study Arms (2)

Lirentelimab (AK002)

EXPERIMENTAL

Subjects in this arm will receive lirentelimab (AK002) administered subcutaneously.

Drug: Lirentelimab (AK002)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Lirentelimab (AK002) DRUG

Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8

Also known as: AK002

Lirentelimab (AK002)

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject is able to understand the information on the study, has the capacity to consent, and has provided written informed consent.
• Male and female subjects ≥18 years of age at the time of screening.
• CSU diagnosis for ≥6 months.
• Diagnosis of moderate-severe CSU refractory to H1-antihistamine (H1-AH) at a minimum of the licensed dose at the licensed frequency at the time of randomization as defined by the following: presence of hives and itch for ≥6 consecutive weeks prior to Screening Visit 1; UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥8 during the 7 days prior to randomization.
• Subjects that are omalizumab-naïve or omalizumab-exposed.
• Subjects must be on stable dose of H1-AH, between 1x and 4x of the licensed dose and at the licensed frequency, for treatment of CSU for at least 1 week prior to screening and willing to remain on a stable dose throughout the study.
• Able and compliant with completing a daily symptom eDiary for the duration of the study and adherent to the study visit schedules.

You may not qualify if:

• History of hypersensitivity to the study drugs or their excipients or to drugs of similar chemical classes (i.e., murine, chimeric or human antibodies).
• Current use of biologics for any indication.
• Demonstrated lack of primary response to treatment with a biologic therapy (e.g., omalizumab) for the treatment of CSU.
• Use of any of the following treatments within 4 weeks prior to the baseline visit or any condition that in the opinion of the Investigator is likely to require such treatment(s) during the first 4 weeks of study treatment: (i) immunosuppressive or immunomodulatory drugs, including but not limited to systemic calcineurin inhibitors (e.g., cyclosporin, tacrolimus), mTOR inhibitors (e.g., sirolimus, everolimus), anti-metabolites (e.g., azathioprine, methotrexate, 6-mercaptopurine, leflunomide, mycophenolate mofetil), alkylating agents (e.g., cyclophosphamide), TNF inhibitors (e.g., infliximab, adalimumab), and eosinophil-depleting drugs (e.g., benralizumab, pramipexole); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic hydroxychloroquine; (iii) intravenous immunoglobulin (IVIG); (iv) plasmapheresis.
• Use of oral Janus kinase (JAK) inhibitors within 8 weeks of the baseline visit.
• Use of any of the following treatments within 3 weeks prior to the baseline visit: (i) H2 antihistamines (H2-AH); (ii) routine (daily or every other day during 5 or more consecutive days) doses of systemic corticosteroids; (iii) regular (daily or every other day) doxepin (oral); (iv) leukotriene receptor antagonists (LTRA) (e.g., montelukast, zafirlukast).
• H1-AH use at greater than approved doses or greater than local CSU guideline recommended doses after Screening Visit 1.
• Previous treatment with biologics: (i) any cell-depleting agents including but not limited to rituximab within 6 months prior to the baseline visit or until lymphocyte count returns to normal, whichever is longer; (ii) other biologics, including investigational biologics (e.g., dupilumab, omalizumab, benralizumab, etc) within 5 half-lives if known or 8 weeks prior to the baseline visit, whichever is longer.
• Planned or anticipated use of any prohibited medication.
• Subjects having causes other than CSU for their urticaria including symptomatic dermographism, cholinergic urticaria, or any inducible urticaria.
• Subjects with known or suspected urticarial vasculitis.
• Subjects with known or suspected hereditary angioedema.
• Any other skin disease associated with chronic itch, including atopic dermatitis, that in the Investigator's opinion might influence study outcome and subject's interpretation of symptoms caused by CSU.
• A helminth parasitic infection diagnosed within 6 months prior to the date that informed consent is obtained and has not been treated with or has failed to respond to standard-of-care therapy.
• Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to study drug administration (or 90 days or 5 half-lives, whichever is longer, for biologic products).

Sponsors & Collaborators

• Allakos Inc.: lead

Study Sites (67)

Allakos Investigational Site 227-024

Birmingham, Alabama, 35209, United States

Location

Allakos Investigational Site 227-068

Cullman, Alabama, 35058, United States

Location

Allakos Investigational Site 227-014

Phoenix, Arizona, 85021, United States

Location

Allakos Investigational Site 227-023

Scottsdale, Arizona, 85251, United States

Location

Allakos Investigational Site 227-058

Bakersfield, California, 93301, United States

Location

Allakos Investigational Site 227-026

Los Angeles, California, 90025, United States

Location

Allakos Investigational Site 227-009

Los Angeles, California, 90045, United States

Location

Allakos Investigational Site 227-011

Mission Viejo, California, 92691, United States

Location

Allakos Investigational Site 227-021

Santa Monica, California, 90404, United States

Location

Allakos Investigational Site 227-031

Upland, California, 91786, United States

Location

Allakos Investigational Site 227-006

Colorado Springs, Colorado, 80907, United States

Location

Allakos Investigational Site 227-036

Jacksonville, Florida, 32256, United States

Location

Allakos Investigational Site 227-062

Miami, Florida, 33135, United States

Location

Allakos Investigational Site 227-041

Sarasota, Florida, 34239, United States

Location

Allakos Investigational Site 227-067

Tampa, Florida, 33607, United States

Location

Allakos Investigational Site 227-005

Tampa, Florida, 33613, United States

Location

Allakos Investigational Site 227-018

Columbus, Georgia, 31904, United States

Location

Allakos Investigational Site 227-045

Boise, Idaho, 83706, United States

Location

Allakos Investigational Site 227-045

Normal, Illinois, 61761, United States

Location

Allakos Investigational Site 227-057

River Forest, Illinois, 60305, United States

Location

Allakos Investigational Site 227-074

Plainfield, Indiana, 46168, United States

Location

Allakos Investigational Site 227-047

Overland Park, Kansas, 66211, United States

Location

Allakos Investigational Site 227-051

Lexington, Kentucky, 40509, United States

Location

Allakos Investigational Site 227-019

Baltimore, Maryland, 21224, United States

Location

Allakos Investigational Site 227-012

Towson, Maryland, 21204, United States

Location

Allakos Investigational Site 227-063

White Marsh, Maryland, 21162, United States

Location

Allakos Investigational Site 227-016

Boston, Massachusetts, 02111, United States

Location

Allakos Investigational Site 227-034

Ann Arbor, Michigan, 48106, United States

Location

Allakos Investigational Site 227-032

Detroit, Michigan, 48202, United States

Location

Allakos Investigational Site 227-070

Farmington Hills, Michigan, 48346, United States

Location

Allakos Investigational Site 227-073

Dilworth, Minnesota, 56529, United States

Location

Allakos Investigational Site 227-052

Rochester, Minnesota, 55905, United States

Location

Allakos Investigational Site 227-008

St Louis, Missouri, 63141, United States

Location

Allakos Investigational Site 227-059

Missoula, Montana, 59808, United States

Location

Allakos Investigational Site 227-022

Brooklyn, New York, 11203, United States

Location

Allakos Investigational Site 227-007

Great Neck, New York, 11021, United States

Location

Allakos Investigational Site 227-002

Asheville, North Carolina, 28801, United States

Location

Allakos Investigational Site 227-013

Cincinnati, Ohio, 45229, United States

Location

Allakos Investigational Site 227-029

Cincinnati, Ohio, 45236, United States

Location

Allakos Investigational Site 227-043

Columbus, Ohio, 43235, United States

Location

Allakos Investigational Site 227-064

Toledo, Ohio, 43617, United States

Location

Allakos Investigational Site 227-060

Oklahoma City, Oklahoma, 73170, United States

Location

Allakos Investigational Site 227-027

Portland, Oregon, 97223, United States

Location

Allakos Investigational Site 227-028

Hershey, Pennsylvania, 17033, United States

Location

Allakos Investigational Site 227-040

Philadelphia, Pennsylvania, 19103, United States

Location

Allakos Investigational Site 227-066

North Charleston, South Carolina, 29420, United States

Location

Allakos Investigational Site 227-055

Austin, Texas, 78759, United States

Location

Allakos Investigational Site 227-049

El Paso, Texas, 79903, United States

Location

Allakos Investigational Site 227-039

Murray, Utah, 84107, United States

Location

Allakos Investigational Site 227-071

Murray, Utah, 84107, United States

Location

Allakos Investigational Site 227-033

Greenfield, Wisconsin, 53228, United States

Location

Allakos Investigational Site 227-204

Augsburg, 86179, Germany

Location

Allakos Investigational Site 227-201

Berlin, 12203, Germany

Location

Allakos Investigational Site 227-214

Buxtehude, 21614, Germany

Location

Allakos Investigational Site 227-205

Darmstadt, 64297, Germany

Location

Allakos Investigational Site 227-209

Erlangen, 91054, Germany

Location

Allakos Investigational Site 227-208

Frankfurt, 60590, Germany

Location

Allakos Investigational Site 227-207

Langenau, 89129, Germany

Location

Allakos Investigational Site 227-203

Leipzig, 04103, Germany

Location

Allakos Investigational Site 227-210

Mainz, 55128, Germany

Location

Allakos Investigational Site 227-202

Mainz, 55131, Germany

Location

Allakos Investigational Site 227-211

Munich, 80802, Germany

Location

Allakos Investigational Site 227-206

Osnabrück, 49074, Germany

Location

Allakos Investigational Site 227-302

Lodz, Poland

Location

Allakos Investigational Site 227-304

Lodz, Poland

Location

Allakos Investigational Site 227-303

Lublin, Poland

Location

Allakos Investigational Site 227-301

Zabrze, Poland

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

AK002

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information
• Organization: Allakos

medinfo@allakos.com

650-597-5002

Study Officials

• Chin Lee, MD, MPH

  Allakos 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: October 26, 2022
• Primary Completion: December 27, 2023
• Study Completion: April 18, 2024
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4); DE (12); US (51)