Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial

NCT05334368 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 217013
• Study Type: interventional
• Target: 123
• Locations: 21 countries
• Sites: 91

Brief Summary

This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.

Conditions

Hypereosinophilic Syndrome

Keywords

Depemokimab; Hypereosinophilic Syndrome; DESTINY; Monoclonal antibody; Anti-interleukin -5

Outcome Measures

Primary Outcomes (1)

• Frequency of HES flares

  A HES flare is defined as either: a HES-related clinical manifestation based on a physician documented change in clinical signs or symptoms resulting in the need for the following : An increase in the maintenance systemic corticosteroid dose by at least 10 mg/day (prednisone/prednisolone equivalent) for at least 5 days, and/or an increase in or addition of any cytotoxic and/or immunosuppressive HES therapy. OR 2 or more courses of blinded active oral corticosteroid (OCS) during the intervention period. The frequency of HES flares will be calculated for each participant as the number of unique starting dates for HES flares.

  Up to 52 weeks

Secondary Outcomes (3)

• Time to first HES flare

  Up to 52 weeks

• Number of participants with at least one HES flare during the 52-week study intervention period

  Up to 52 weeks

• Change from Baseline to Week 52 in weekly average score of Brief Fatigue Inventory (BFI) item 3 (worst fatigue in last 24 hours)

  Baseline and up to Week 52

Study Arms (2)

Depemokimab

EXPERIMENTAL

All participants in this arm will receive depemokimab.

Drug: Depemokimab

Placebo

PLACEBO COMPARATOR

All participants in this arm will receive placebo.

Other: Placebo

Interventions

Depemokimab DRUG

Depemokimab will be administered.

Depemokimab

Placebo OTHER

Matching placebo will be administered.

Placebo

Eligibility Criteria

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

You may qualify if:

• Participants who are greater than or equal (\>=) 40 kilogram (kg) at Screening Visit 1.
• Participants who have a documented diagnosis of HES prior to Visit 2.
• A history of 2 or more HES flares within the past 12 months prior to Visit 1.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: a) woman of non-childbearing potential (WONCBP) Or b) woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\<) 1 percentage (%).
• Capable of giving signed informed consent.

You may not qualify if:

• Participants with HES disease manifestations which in the opinion of the investigator may put the participant at unacceptable risk from study participation or confound interpretation of efficacy or safety data.
• Participants with chronic or ongoing active infections requiring systemic treatment or a pre-existing parasitic infestation within 6 months prior to Visit 1.
• Participants with a known immunodeficiency (e.g., Human Immunodeficiency Virus \[HIV\]), other than that explained by the use of OCS or other therapy taken for HES.
• Participants with a history of or current lymphoma.
• Participants with current malignancy or previous history of cancer in remission for less than 5 years prior to Visit 1. Participants that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
• Participants with a haematologic malignancy with hypereosinophilia in which HES is not the primary diagnosis, e.g., chronic myeloid leukaemia, myelodysplastic syndrome, chronic eosinophilic leukaemia-not otherwise specified.
• Cirrhosis or current unstable liver or biliary disease per investigator assessment.
• Participants who have severe or clinically significant cardiovascular disease uncontrolled with standard treatment.
• Participants with current diagnosis of vasculitis.
• Hypereosinophila with no clinical symptoms and/or proof of organ dysfunction.
• Clinical diagnosis of Eosinophilic granulomatosis with polyangiitis (EGPA).
• Participants with an allergy/ intolerance to a monoclonal antibody or biologic, or any of the excipients of the investigational product.
• Participants who have a previous documented failure with anti-interleukin (IL)-5/5R therapy.
• Participants who have received monoclonal antibodies (mAb) within 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
• Participants who test positive for the FIP1L1-PDGFRα fusion gene.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (91)

GSK Investigational Site

San Diego, California, 920237, United States

RECRUITING

GSK Investigational Site

Atlanta, Georgia, 30322, United States

RECRUITING

GSK Investigational Site

Boston, Massachusetts, 02111, United States

RECRUITING

GSK Investigational Site

Southfield, Michigan, 48075, United States

WITHDRAWN

GSK Investigational Site

Rochester, Minnesota, 55905, United States

WITHDRAWN

GSK Investigational Site

Manhasset, New York, 11030, United States

COMPLETED

GSK Investigational Site

Cincinnati, Ohio, 45229, United States

RECRUITING

GSK Investigational Site

Columbus, Ohio, 43212, United States

RECRUITING

GSK Investigational Site

Charleston, South Carolina, 29425, United States

RECRUITING

GSK Investigational Site

Nashville, Tennessee, 37208, United States

COMPLETED

GSK Investigational Site

Salt Lake City, Utah, 84132, United States

RECRUITING

GSK Investigational Site

Buenos Aires, C1425BEN, Argentina

RECRUITING

GSK Investigational Site

Florida, 1602, Argentina

RECRUITING

GSK Investigational Site

La Plata, B1900, Argentina

RECRUITING

GSK Investigational Site

Mar del Plata, 7600, Argentina

RECRUITING

GSK Investigational Site

Quilmes, 1878, Argentina

RECRUITING

GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

COMPLETED

GSK Investigational Site

Brussels, 1070, Belgium

RECRUITING

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

GSK Investigational Site

Blumenau, 89030-101, Brazil

RECRUITING

GSK Investigational Site

Rio de Janeiro, 21.941-913, Brazil

RECRUITING

GSK Investigational Site

Sorocaba, 18040-425, Brazil

RECRUITING

GSK Investigational Site

Ottawa, Ontario, K1H 1E4, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

GSK Investigational Site

Beijing, 100730, China

RECRUITING

GSK Investigational Site

Changsha, 410008, China

RECRUITING

GSK Investigational Site

Guangzhou, 510080, China

RECRUITING

GSK Investigational Site

Guangzhou, 510515, China

RECRUITING

GSK Investigational Site

Harbin, 150010, China

RECRUITING

GSK Investigational Site

Nanchang, 330006, China

RECRUITING

GSK Investigational Site

Shanghai, 200025, China

RECRUITING

GSK Investigational Site

Suzhou, 215006, China

RECRUITING

GSK Investigational Site

Wuhan, 430022, China

RECRUITING

GSK Investigational Site

Brno-Bohunice, 625 00, Czechia

RECRUITING

GSK Investigational Site

Hradec Králové, 500 05, Czechia

RECRUITING

GSK Investigational Site

Prague, 14059, Czechia

RECRUITING

GSK Investigational Site

Ústí nad Labem, 40113, Czechia

RECRUITING

GSK Investigational Site

Odense C, 5000, Denmark

RECRUITING

GSK Investigational Site

Bad Bramstedt, 24576, Germany

RECRUITING

GSK Investigational Site

Mannheim, 68167, Germany

RECRUITING

GSK Investigational Site

Athens, 10676, Greece

RECRUITING

GSK Investigational Site

Rio Patras, 26054, Greece

WITHDRAWN

GSK Investigational Site

Pokfulam, Hong Kong

RECRUITING

GSK Investigational Site

Ramat Gan, 52621, Israel

RECRUITING

GSK Investigational Site

Tel Aviv, 64239, Israel

RECRUITING

GSK Investigational Site

Bologna, 40138, Italy

RECRUITING

GSK Investigational Site

Catania, 95123, Italy

RECRUITING

GSK Investigational Site

Milan, 20132, Italy

RECRUITING

GSK Investigational Site

Napoli, 80131, Italy

RECRUITING

GSK Investigational Site

Novara, 28100, Italy

RECRUITING

GSK Investigational Site

Pavia, 27100, Italy

RECRUITING

GSK Investigational Site

Roma, 00168, Italy

RECRUITING

GSK Investigational Site

Treviso, 31100, Italy

RECRUITING

GSK Investigational Site

Verona, 37134, Italy

RECRUITING

GSK Investigational Site

Aomori, 030-8553, Japan

RECRUITING

GSK Investigational Site

Aomori, 036-8563, Japan

RECRUITING

GSK Investigational Site

Chiba, 272-8516, Japan

RECRUITING

GSK Investigational Site

Gifu, 509-6134, Japan

RECRUITING

GSK Investigational Site

Hyōgo, 670-8540, Japan

RECRUITING

GSK Investigational Site

Kanagawa, 259-1143, Japan

RECRUITING

GSK Investigational Site

Miyagi, 980-8574, Japan

RECRUITING

GSK Investigational Site

Tokyo, 105-8471, Japan

RECRUITING

GSK Investigational Site

Tokyo, 142-8666, Japan

RECRUITING

GSK Investigational Site

Wakayama, 641-8509, Japan

RECRUITING

GSK Investigational Site

Yamanashi, 409-3898, Japan

RECRUITING

GSK Investigational Site

Guadalajara, 44130, Mexico

RECRUITING

GSK Investigational Site

Monterrey, 64060, Mexico

RECRUITING

GSK Investigational Site

Veracruz, 94534, Mexico

RECRUITING

GSK Investigational Site

Chęciny, 26-060, Poland

RECRUITING

GSK Investigational Site

Lodz, 90-153, Poland

RECRUITING

GSK Investigational Site

Bucharest, 31281, Romania

RECRUITING

GSK Investigational Site

Cluj-Napoca, 400124, Romania

RECRUITING

GSK Investigational Site

Gwangju, 61469, South Korea

RECRUITING

GSK Investigational Site

Jeonju, 561-712, South Korea

RECRUITING

GSK Investigational Site

Kangwondo, 26426, South Korea

RECRUITING

GSK Investigational Site

Seoul, 03722, South Korea

RECRUITING

GSK Investigational Site

Seoul, 06351, South Korea

RECRUITING

GSK Investigational Site

Seoul, 06591, South Korea

RECRUITING

GSK Investigational Site

Seoul, 110-744, South Korea

RECRUITING

GSK Investigational Site

Seoul, 136-705, South Korea

RECRUITING

GSK Investigational Site

Seoul, 138-736, South Korea

RECRUITING

GSK Investigational Site

Suwon Kyunggi-do, 16499, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08036, Spain

RECRUITING

GSK Investigational Site

Granada, 18014, Spain

RECRUITING

GSK Investigational Site

Madrid, 28008, Spain

RECRUITING

GSK Investigational Site

Madrid, 28031, Spain

RECRUITING

GSK Investigational Site

Pozuelo de AlarcOn Madr, 28223, Spain

RECRUITING

GSK Investigational Site

Salamanca, 37007, Spain

RECRUITING

GSK Investigational Site

Valencia, 46026, Spain

RECRUITING

GSK Investigational Site

Zaragoza, 50009, Spain

RECRUITING

GSK Investigational Site

Leicester, LE3 9QP, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Hypereosinophilic Syndrome

Condition Hierarchy (Ancestors)

Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double-blind study with respect to allocation of depemokimab or placebo to participants. All site staff, participants, and investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, placebo-controlled, double-blind, parallel group, multicenter study.

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: September 6, 2022
• Primary Completion (Estimated): December 19, 2028
• Study Completion (Estimated): December 19, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

HK (1); JP (11); DE (2); CZ (4); GB (1); CA (2); CN (9); ME (3); IT (9); ES (8); AR (5); BR (4); US (11); DK (1); IL (2); KR (10); PL (2); BE (1); RO (2); GR (2); AU (1)