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Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

  • Clinicaltrials.gov identifier

    NCT04991935

  • Recruitment Status

    Recruiting

  • First Posted

    August 5, 2021

  • Last update posted

    May 12, 2022

Study Description

Brief summary:

This study is an open-label, uncontrolled study design to evaluate the longer-term safety profile as well as durability of response of administration of a single dose level of CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 study.

  • Condition or Disease:Eosinophilic Esophagitis
  • Intervention/Treatment: Drug: CC-93538
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 259 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
  • Actual Study Start Date: September 2021
  • Estimated Primary Completion Date: August 2026
  • Estimated Study Completion Date: August 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
Drug: CC-93538
CC-93538

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of Adverse Events (AEs) [ Time Frame: For a minimum of 28 months ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
  • Secondary Outcome Measures: 1. Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies [ Time Frame: For a minimum of 28 months ]
    This includes neutralizing antibodies when warranted.

Eligibility Criteria

  • Ages Eligible for Study: 12 to 75 Years (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Previously participated in prior clinical study CC-93538-EE-001 and either: completed both the Induction and Maintenance phases; or completed the Induction Phase, however, did not qualify for the Maintenance Phase, including having a severe eosinophilic esophagitis (EoE) flare requiring endoscopic intervention or rescue therapy. Demonstrated compliance with required investigational product dosing during the prior study. Did not permanently discontinue investigational product in the prior study and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing. Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538. Exclusion Criteria: Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study. Active Helicobacter pylori infection or esophageal varices. Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study. Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study. Received an investigational product, other than that administered in CC-93538-EE-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician. Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study. Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality). Active or ongoing infections including parasitic/helminthic infections, viral hepatitis, tuberculosis, or HIV. Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538. Females who are pregnant or lactating.

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Alabama
AES - DRS - Simon Williamson Clinic, PC - Birmingham
Birmingham

United States, Alabama
Gastro Care PC - CAR
Tuscaloosa

United States, Arizona
Phoenix Childrens Hospital
Phoenix

United States, Arizona
AES - DRS - Central Phoenix Medical Clinic, LLC
Phoenix

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale

United States, Arizona
Del Sol Research Management
Tucson

United States, Arizona
MetroHealth Medical Center
Tucson

United States, California
OM Research
Lancaster

United States, California
OM Research
Lancaster

United States, California
Gastrointestinal Biosciences
Los Angeles

United States, California
UCSF Benioff Children's Hospital Oakland
Oakland

United States, California
Palmtree Clinical Research
Palm Springs

United States, California
Alliance Clinical Research, LLC
Poway

United States, California
SDG Clinical Research, Inc.
San Diego

United States, California
Precision Research Institute, LLC
San Diego

United States, Colorado
Childrens Hospital Colorado
Aurora

United States, Colorado
Peak Gastroenterology Associates
Colorado Springs

United States, Colorado
Rocky Mountain Pediatric Gastroenterology
Denver

United States, Colorado
Western States Clinical Research Inc
Wheat Ridge

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Connecticut
University of Connecticut
Farmington

United States, Connecticut
Medical Research Center of Connecticut LLC
Hamden

United States, District of Columbia
Children's National Medical Center
Washington

United States, Florida
Gastro Florida
Clearwater

United States, Florida
Nature Coast Clinical Research LLC
Inverness

United States, Florida
Nature Coast Clinical Research LLC
Inverness

United States, Florida
ENCORE Borland-Groover Clinical Research
Jacksonville

United States, Florida
ENCORE Borland-Groover Clinical Research
Jacksonville

United States, Florida
Homestead Associates in Research Inc
Miami

United States, Florida
A Plus Research Inc
Miami

United States, Florida
Med-Care Research
North Miami Beach

United States, Florida
AES - DRS - Synexus Clinical Research US, Inc. - Orlando
Orlando

United States, Florida
Arnold Palmer Hospital For Children
Orlando

United States, Florida
Gastroenterology Consultants of Central Florida - CAR
Orlando

United States, Florida
Advanced Medical Research Center
Port Orange

United States, Florida
US Associates in Research Inc
Sweetwater

United States, Georgia
Emory University
Atlanta

United States, Georgia
Gastroenterology Associates Of Central Georgia LLC
Macon

United States, Idaho
Grand Teton Research Group PLLC
Idaho Falls

United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago

United States, Illinois
University of Chicago
Chicago

United States, Indiana
Indiana University
Indianapolis

United States, Indiana
Gastroenterology Health Partners PLLC
New Albany

United States, Iowa
Iowa Digestive Disease Center
Clive

United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City

United States, Kansas
University of Kansas Medical Center
Kansas City

United States, Kentucky
Tri-State Gastroentrology Associates
Florence

United States, Kentucky
University of Louisville
Louisville

United States, Louisiana
Gastroenterology Associates LLC
Baton Rouge

United States, Louisiana
Clinical Trials Management LLC
Metairie

United States, Louisiana
Clinical Trials Management LLC
Metairie

United States, Louisiana
Ochsner Children's Health Center
New Orleans

United States, Maryland
Johns Hopkins University
Baltimore

United States, Maryland
Digestive Disease Associates, PA
Catonsville

United States, Maryland
Woodholme Gastroenterology Associates
Glen Burnie

United States, Maryland
Meritus Medical Center
Hagerstown

United States, Massachusetts
Tufts - New England Medical Center
Boston

United States, Massachusetts
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston

United States, Massachusetts
Boston Children's Hospital
Boston

United States, Massachusetts
Brigham and Women's Hospital
Boston

United States, Massachusetts
Greater Boston Gastroenterology PC
Framingham

United States, Massachusetts
FC Research LLC
South Dartmouth

United States, Massachusetts
Baystate Medical Center
Springfield

United States, Massachusetts
UMASS Memorial Hospital
Worcester

United States, Michigan
Troy Gastroenterology
Troy

United States, Michigan
Gastroenterology Associates of Western Michigan PLC
Wyoming

United States, Minnesota
Minnesota Gastroenterology
Plymouth

United States, Minnesota
Mayo Clinic
Rochester

United States, Mississippi
GI Associates and Endoscopy Center-GI Clinical Research Department
Flowood

United States, Missouri
Mid America Gastrointestinal Consultants
Kansas City

United States, Missouri
Washington University Siteman Cancer Center
Saint Louis

United States, Nebraska
University of Nebraska Medical Center
Omaha

United States, Nevada
Advanced Research Institute - Reno
Reno

United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon

United States, New Jersey
Atlantic Research Center LLC
Ocean City

United States, New Mexico
New Mexico Clinical Research and Osteoporosis Center
Albuquerque

United States, New York
Long Island Gastrointestinal Research Group LLP
Great Neck

United States, New York
Drug Trials America
Hartsdale

United States, New York
NYU Langone Medical Center
New York

United States, New York
Dr. Jeffrey Crespin, MD - New York - CAR
New York

United States, New York
Icahn School of Medicine at Mount Sinai
New York

United States, New York
Rochester Gastroenterology: Devgun Surinder MD
Rochester

United States, New York
Hill Medical Center
Syracuse

United States, New York
Syracuse VA Medical Center
Syracuse

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill

United States, North Carolina
Clinical Research of Charlotte
Charlotte

United States, North Carolina
Duke University Medical Center
Durham

United States, North Carolina
Medication Management LLC
Greensboro

United States, North Carolina
Atlantic Medical Group - Kinston - CAR
Kinston

United States, Ohio
Dayton Gastroenterology, Inc
Beavercreek

United States, Ohio
Consultants for Clinical Research
Cincinnati

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati

United States, Ohio
University of Cincinnati Medical Center
Cincinnati

United States, Ohio
Cleveland Clinic Foundation
Cleveland

United States, Ohio
The Cleveland Clinic Foundation
Cleveland

United States, Ohio
AES - DRS - Synexus Clinical Research US, Inc. - Columbus
Columbus

United States, Ohio
Optimed Research Ltd
Columbus

United States, Ohio
Optimed Research Ltd
Columbus

United States, Oregon
Velocity Clinical Research - Grants Pass - ERN - PPDS
Medford

United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey

United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia

United States, Pennsylvania
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia

United States, Pennsylvania
Thomas Jefferson University
Philadelphia

United States, Pennsylvania
Glenn S Freed, DO - CAR
Pottsville

United States, Rhode Island
University Gastroenterology
Providence

United States, South Carolina
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
Anderson

United States, South Carolina
Prisma Health - Upstate
Greenville

United States, Tennessee
ClinSearch LLC
Chattanooga

United States, Tennessee
Vanderbilt University
Nashville

United States, Texas
Texas Digestive Disease Consultants Dallas
Cedar Park

United States, Texas
AES - DRS - Synexus Clinical Research US, Inc. - Dallas
Dallas

United States, Texas
Childrens Medical Center
Dallas

United States, Texas
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston

United States, Texas
Cook Childrens Medical Center
Fort Worth

United States, Texas
Houston Endoscopy and Research Center
Houston

United States, Texas
Digestive Health Associates of Texas (DHAT)
Rockwell

United States, Texas
Southern Star Research Institute LLC
San Antonio

United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake

United States, Texas
Tyler Research Institute, LLC
Tyler

United States, Utah
Intermountain Clinical Research
Draper

United States, Utah
Ogden Clinic Gastrenterology - CAR
Ogden

United States, Utah
Advanced Research Institute-South Ogden
Ogden

United States, Utah
University of Utah Primary Children's Medical Center
Salt Lake City

United States, Utah
University of Utah School of Medicine
Salt Lake City

United States, Vermont
University of Vermont Medical Center Gastro
Burlington

United States, Virginia
Emeritas Research Group
Leesburg

United States, Virginia
Blue Ridge Medical Research
Lynchburg

United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond

United States, Virginia
Carilion Clinic
Roanoke

United States, Washington
Velocity Clinical Research - Spokane - ERN - PPDS
Spokane

United States, Washington
Vancouver Clinic Inc PS
Vancouver

United States, Wisconsin
University of Wisconsin
Madison

United States, Wisconsin
Aurora Saint Lukes Medical Center
Milwaukee

United States, Wisconsin
Medical College of Wisconsin
Milwaukee

United States, Wyoming
Gastroenterology Associates, PC - Casper - CAR
Casper

Argentina
Hospital Italiano de Buenos Aires
Buenos Aires

Argentina
Gedyt
BuenosAires

Argentina
Centro de Investigaciones Medica Mar del Plata
Mar Del Plata

Argentina
Instituto CER S.A.
Quilmes

Argentina
Investigaciones En Patologias Respiratorias
San Miguel de Tucumán

Australia, New South Wales
Concord Repatriation General Hospital
Concord

Australia, New South Wales
Liverpool Hospital
Liverpool

Australia, New South Wales
The Childrens Hospital at Westmead
Westmead

Australia, Queensland
Coastal Digestive Health
Maroorchydore

Australia, Queensland
Coral Sea Clinical Research Institute
North Mackay

Australia, Queensland
Mater Adult Hospital
South Brisbane

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale

Australia, Victoria
Monash Health, Monash Medical Centre
Clayton

Australia, Victoria
Footscray Hospital
Footscray

Australia, Victoria
The Alfred Hospital
Melbourne

Australia, Western Australia
Fiona Stanley Hospital
Murdoch

Australia
St Vincents Hospital Melbourne
Fitzroy

Australia
St John of God Midland Hospital
Western Australia

Austria
Krankenhaus der Barmherzigen Brüder Eisenstadt
Burgenland

Austria
LKH-Universitätsklinikum Klinikum Graz
Graz

Austria
Hospital of Barmherzige Schwestern Linz
Linz

Austria
Medizinische Universitat Wien
Vienna

Belgium
UZ Brussel
Brussels

Belgium
AZ Groeninge
Kortrijk

Belgium
UZ Leuven
Leuven

Belgium
AZ Sint-Lucas Brugge
West-Vlaanderen

Canada, Alberta
University of Calgary
Calgary

Canada, Alberta
University of Alberta
Edmonton

Canada, Alberta
South Edmonton Gastroenterology
Edmonton

Canada, British Columbia
GI Research Institute
Vancouver

Canada, British Columbia
PerCuro Clinical Research LTD
Victoria

Canada, Ontario
Ottawa Allergy Research Corporation
Ottawa

Canada, Ontario
Toronto Western Hospital
Toronto

Canada, Ontario
Toronto Digestive Disease Associates Inc
Vaughan

Germany
Staedisches Klinikum Brandenburg
Brandenburg an der Havel

Germany
AES - DRS - Synexus Frankfurt Research Centre
Frankfurt am Main

Germany
Klinikum Garmisch-Partenkirchen Gmbh
Garmisch-Partenkirchen

Germany
Facharztzentrum Eppendorf
Hamburg

Germany
Universitatsklinikum Leipzig
Leipzig

Germany
EUGASTRO GmbH
Leipzig

Germany
Gastroenterologische Gemeinschaftspraxis Mainz
Mainz

Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Munchen

Germany
Praxis Prof. Herbert Kellner
München

Israel
Rambam Medical Center
Haifa

Israel
Edith Wolfson Medical Center
Holon

Israel
Shaare Zedek Medical Center
Jerusalem

Israel
Hadassah Medical Center
Jerusalem

Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv

Israel
Shamir Medical Center - Assaf Harofeh
Zerifin

Italy
Ospedale Policlinico San Martino
Genova

Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano

Italy
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli

Italy
Azienda Ospedaliera di Padova
Padova

Italy
Azienda Ospedaliera Universitaria Pisana
Pisa

Italy
Azienda Policlinico Umberto I
Rome

Japan
Akita University Hospital
Akita-shi

Japan
Nippon Medical School Hospital
Bunkyo-ku

Japan
Tokai University Hospital
Isehara City, Kanagawa

Japan
Kobe University Hospital
Kobe

Japan
Local Institution - 597
Kobe

Japan
Gunma University Hospital
Maebashi

Japan
Daido Clinic
Nagoya

Japan
Nagoya City University Hospital
Nagoya

Japan
Niigata University Medical and Dental Hospital
Niigata-shi

Japan
Hyogo College of Medicine Hospital
Nishinomiya

Japan
Kawasaki Medical School Hospital
Okayama-Shi

Japan
Osaka City University Hospital
Osaka

Japan
Gunma Children's Medical Center
Shibukawa

Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku

Japan
International University of Health and Werfare Mita Hospital
Tokyo

Japan
Local Institution - 605
Tokyo

Japan
National Center for Child Health and Development
Tokyo

Japan
Fujita Health University Hospital
Toyoake

Japan
Local Institution - 596
Toyoake

Japan
Yamagata University Hospital
Yamagata

Poland
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz

Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Czestochowa

Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk

Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice

Poland
AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi
Lódz

Poland
TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC
Szczecin

Poland
WIP Warsaw IBD Point
Warsaw

Poland
Centrum Zdrowia MDM
Warszawa

Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warszawa

Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw

Poland
Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw

Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw

Portugal
Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos
Lisboa

Portugal
Centro Hospitalar Lisboa Central- Hospital Dona Estefânia
Lisboa

Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto

Portugal
Centro Hospitalar de São João, E.P.E.
Porto

Spain
Hospital Clinic de Barcelona
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital La Princesa
Madrid

Spain
Hospital Universitario La Paz
Madrid

Spain
Hospital Costa del Sol
Marbella

Spain
Hospital Virgen del Rocio
Sevilla

Switzerland
Chuv Bh-04
Lausanne

Switzerland
Kantonsspital Liestal
Liestal

United Kingdom
Belfast Health and Social Care Trust
Belfast Northern Ireland

United Kingdom
AES - DRS - Synexus Midlands Clinical Research Centre
Birmingham

United Kingdom
Addenbrooke's Hospital
Cambridge

United Kingdom
AES - DRS - Synexus Wales Clinical Research Centre
Cardiff

United Kingdom
AES - DRS - NW Consortium Lancashire
Chorley

United Kingdom
AES - DRS - Synexus North Teesside Clinical Research Centre
Hardwick

United Kingdom
AES - DRS - Synexus Hexham Clinical Research Centre
Hexam

United Kingdom
AES - DRS - NW Consortium Merseyside
Liverpool

United Kingdom
Royal Manchester Children's Hospital
Manchester

United Kingdom
AES - DRS - NW Consortium Manchester
Manchester

United Kingdom
Southampton General Hospital
Southampton

Sponsors and Collaborators

Celgene

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04991935 History of Changes
  • Other Study ID Numbers: CC-93538-EE-002, 2020-004335-24
  • First Posted: August 5, 2021 Key Record Dates
  • Last Update Posted: May 12, 2022
  • Last Verified: May 2022
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Eosinophilic Esophagitis
    CC-93538
    RPC4046
    Adult
    Adolescent
    Gastrointestinal Diseases
    Esophagitis
    Gastroenteritis
    Eosinophils
    Eosinophilia
    Esophageal Diseases
    Allergic Diseases
    Antibody, Monoclonal
    Hypersensitivity
    Immunologic factors
    Physiological Effects of Drugs
  • Additional relevant MeSH terms: Esophagitis
    Eosinophilic Esophagitis
    Esophageal Diseases
    Gastrointestinal Diseases
    Digestive System Diseases
    Gastroenteritis
    Eosinophilia
    Leukocyte Disorders
    Hematologic Diseases
    Hypersensitivity, Immediate
    Hypersensitivity
    Immune System Diseases