Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (DESTINY)

November 24, 2025 updated by: GlaxoSmithKline

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults With Hypereosinophilic Syndrome (HES)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425BEN
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anahí Yañez
        • Contact:
        • Contact:
      • Florida, Argentina, 1602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Angel A Bergna
      • La Plata, Argentina, B1900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Juan Magri
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Wehbe
      • Quilmes, Argentina, 1878
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marcelo José Fernández
        • Contact:
        • Contact:
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • Completed
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Florence Roufosse
  • Brazil
      • Blumenau, Brazil, 89030-101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marina Lima
      • Rio de Janeiro, Brazil, 21.941-913
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Solange Valle
      • Sorocaba, Brazil, 18040-425
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Martti Anton Antila
        • Contact:
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Fogliatto
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 1E4
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Olynych
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hassan Sibai
  • China
      • Beijing, China, 100730
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daobin Zhou
      • Changsha, China, 410008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yajing Xu
      • Guangzhou, China, 510080
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xin Du
        • Contact:
        • Contact:
      • Guangzhou, China, 510515
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Na Xu
      • Harbin, China, 150010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Ma
      • Nanchang, China, 330006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Fei Li
        • Contact:
        • Contact:
      • Shanghai, China, 200025
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Junmin Li
        • Contact:
        • Contact:
      • Suzhou, China, 215006
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Suning Chen
        • Contact:
        • Contact:
      • Wuhan, China, 430022
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yu Hu
        • Contact:
        • Contact:
  • Czechia
      • Brno - Bohunice, Czechia, 625 00
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Doubek
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Irena Krcmova
        • Contact:
        • Contact:
      • Prague, Czechia, 14059
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucie Heribanova
      • Ústí nad Labem, Czechia, 40113
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dalibor Jilek
  • Denmark
      • Odense C, Denmark, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gunhild Nynke Thomsen
  • Germany
      • Bad Bramstedt, Germany, 24576
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ina Kötter
      • Mannheim, Germany, 68167
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juliana Schwaab
  • Greece
      • Athens, Greece, 10676
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Pagoni
      • Rio Patras, Greece, 26054
        • Withdrawn
        • GSK Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yok Lam Kwong
  • Israel
      • Ramat Gan, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nancy Agmon Levin
      • Tel Aviv, Israel, 64239
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Hagin
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Papayannidis
        • Contact:
        • Contact:
      • Catania, Italy, 95123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandra Romano
      • Milan, Italy, 20132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorenzo Dagna
      • Napoli, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabrizio Pane
      • Novara, Italy, 28100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrea Patriarca
        • Contact:
        • Contact:
      • Pavia, Italy, 27100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chiara Elena
        • Contact:
        • Contact:
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Antonietta D'Agostino
      • Treviso, Italy, 31100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Cinetto
      • Verona, Italy, 37134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simonetta Friso
  • Japan
      • Aomori, Japan, 030-8553
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kohmei Kubo
      • Aomori, Japan, 036-8563
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hirotake Sakuraba
      • Chiba, Japan, 272-8516
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Toshikazu Kano
        • Contact:
        • Contact:
      • Gifu, Japan, 509-6134
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroyuki Ohbayashi
      • Hyōgo, Japan, 670-8540
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yasushi Hiramatsu
        • Contact:
        • Contact:
      • Kanagawa, Japan, 259-1143
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yoshiaki Ogawa
        • Contact:
        • Contact:
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomonori Ishii
        • Contact:
        • Contact:
      • Tokyo, Japan, 142-8666
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hironori Sagara
      • Tokyo, Japan, 105-8471
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takeshi Saito
      • Wakayama, Japan, 641-8509
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Sonoki
      • Yamanashi, Japan, 409-3898
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Keita Kirito
        • Contact:
        • Contact:
  • Mexico
      • Guadalajara, Mexico, 44130
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Efrain Montaño Gonzalez
        • Contact:
        • Contact:
      • Monterrey, Mexico, 64060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Glenn Valdez Lopez
      • Veracruz, Mexico, 94534
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Antonio Autran- Limón del Prado
  • Poland
      • Chęciny, Poland, 26-060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Piotr Łacwik
      • Lodz, Poland, 90-153
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marta Kolacinska-Flont
  • Romania
      • Bucharest, Romania, 31281
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Viola Maria Popov
      • Cluj-Napoca, Romania, 400124
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mihnea Tudor Zdrenghea
        • Contact:
        • Contact:
  • South Korea
      • Gwangju, South Korea, 61469
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young-Il Koh
      • Jeonju, South Korea, 561-712
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yong Chul Lee
        • Contact:
        • Contact:
      • Kangwondo, South Korea, 26426
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sang-Ha Kim
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jung-Won Park
        • Contact:
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byung-Jae Lee
      • Seoul, South Korea, 06591
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chin Kook Rhee
        • Contact:
        • Contact:
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tae-Bum Kim
        • Contact:
        • Contact:
      • Seoul, South Korea, 110-744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye-Ryun Kang
      • Seoul, South Korea, 136-705
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sue In Choi
      • Suwon Kyunggi-do, South Korea, 16499
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • YoungSoo Lee
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Georgina Espigol Frigole
        • Contact:
        • Contact:
      • Granada, Spain, 18014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Concepción Morales Garcia
        • Contact:
        • Contact:
      • Madrid, Spain, 28031
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jose Angel Hernandez Rivas
        • Contact:
        • Contact:
      • Madrid, Spain, 28008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Concepción Alaez Usón
      • Pozuelo de AlarcOn Madr, Spain, 28223
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aranzazu Alonso
      • Salamanca, Spain, 37007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jesús Maria Hernández Rivas
        • Contact:
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elvira Mora Castera
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gonzalo Caballero Navarro
  • United Kingdom
      • Leicester, United Kingdom, LE3 9QP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shamsa Naveed
  • United States
    • California
      • San Diego, California, United States, 920237
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian Modena
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Frances E Lee
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Leung
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Withdrawn
        • GSK Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • GSK Investigational Site
    • New York
      • Manhasset, New York, United States, 11030
        • Completed
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Rothenberg
        • Contact:
        • Contact:
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Casey Curtis
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kelli Williams
        • Contact:
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Completed
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mili Shum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥450 milliseconds (msec) or QTcF ≥480 msec for participants with Bundle Branch Block at Screening Visit 1.
  • Participants who are not responsive to OCS based on clinical response or blood eosinophil counts in the opinion of the Investigator.
  • Participants who are pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depemokimab
All participants in this arm will receive depemokimab.
Drug: Depemokimab
Depemokimab will be administered.
Placebo Comparator: Placebo
All participants in this arm will receive placebo.
Other: Placebo
Matching placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of HES flares
Time Frame: Up to 52 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first HES flare
Time Frame: Up to 52 weeks
The time to first HES flare will be calculated from the date of first dose of study intervention and the start date of the HES flare. Time to the first HES flare will be assessed and reported in days.
Up to 52 weeks
Number of participants with at least one HES flare during the 52-week study intervention period
Time Frame: Up to 52 weeks
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)
Time Frame: Baseline and up to Week 52
The BFI is a tool developed for the rapid assessment of fatigue severity for use in both clinical Screening and clinical trials. The BFI has 9 items. The participant should rate their average and worst fatigue levels over the previous 24 hours using a numeric rating scale anchored with 0 (no fatigue/interference) and 10 (as bad as you can imagine/completely interferes) numeric rating scales
Baseline and up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2022

Primary Completion (Estimated)

December 19, 2028

Study Completion (Estimated)

December 19, 2028

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Estimated)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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