Phase
Condition
Esophageal Disorders
Heartburn (Pediatric)
Heartburn
Treatment
Tezepelumab
Placebo
Clinical Study ID
Ages 12-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must be 12 to 80 years of age inclusive, at the time of signing theinformed consent/assent.
Weight ≥ 40 kg at Visit 1
Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming adiagnosis of EoE.
Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going down slowly or being stuck inthe throat) per week in the 4 weeks prior to Visit 1.
Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and duringthe course of the study (stable diet is defined as no initiation of single ormultiple elimination diets or reintroduction of previously eliminated food groups).
May be on any background PPI and/or STC, during the course of the study, as long asbackground medications have been stable for at least 8 weeks prior to thescreening/run-in period (Visit 1) and there is agreement not to change backgroundmedication or dosage unless medically indicated, during the screening/run-in andtreatment period.
Participants currently on leukotriene inhibitors and/or steroid treatments forasthma or allergies that are inhaled or administered intranasally, must report astable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).
If a medication for EoE (for example PPI and/or STC) is discontinued prior to thescreening/run-in, there should be a washout period of at least 8 weeks prior toVisit 1. Discontinuation of any marketed biologic (monoclonal or polyclonalantibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1,whichever is longer.
Participants should have previously documented standard of care treatment, whichcould include PPI and/or STC and/or diet.
Exclusion
Exclusion Criteria:
Other gastrointestinal disorders such as active Helicobacter pylori infection,history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis,inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis,diverticulitis, irritable bowel syndrome, or other clinically significantgastrointestinal conditions as per Investigator discretion.
Esophageal stricture that prevents the easy passage of a standard endoscope or anycritical esophageal stricture that requires dilation at screening.
Use of a feeding tube, or having a pattern of not eating solid food >3 days of week.Solid food is defined as food that requires chewing before swallowing.
Hypereosinophilic syndrome
EGPA vasculitis
Esophageal dilation performed within 8 weeks prior to screening.
Study Design
Study Description
Connect with a study center
Research Site
Elizabeth Vale, 5112
AustraliaActive - Recruiting
Research Site
Kogarah, 2217
AustraliaActive - Recruiting
Research Site
Mitcham, 3132
AustraliaSite Not Available
Research Site
South Brisbane, QL 4101
AustraliaActive - Recruiting
Research Site
Woolloongabba, 4102
AustraliaActive - Recruiting
Research Site
Graz, 8036
AustriaSite Not Available
Research Site
Wels-Grieskirchen, 4600
AustriaActive - Recruiting
Research Site
Wien, 1090
AustriaActive - Recruiting
Research Site
Brugge, 8310
BelgiumActive - Recruiting
Research Site
Edegem, 2650
BelgiumActive - Recruiting
Research Site
Gent, 9000
BelgiumActive - Recruiting
Research Site
Leuven, 3000
BelgiumActive - Recruiting
Research Site
Botucatu, 18618-687
BrazilActive - Recruiting
Research Site
Brasilia, 71681-603
BrazilActive - Recruiting
Research Site
Caxias do Sul, 95070-560
BrazilActive - Recruiting
Research Site
Curitiba, 80440-220
BrazilActive - Recruiting
Research Site
Porto Alegre, 90050-170
BrazilSite Not Available
Research Site
Sao Paulo, 05.403-010
BrazilActive - Recruiting
Research Site
São José do Rio Preto, 15090-000
BrazilActive - Recruiting
Research Site
Hamilton, Ontario L8S 1G5
CanadaActive - Recruiting
Research Site
London, Ontario N6A 5W9
CanadaActive - Recruiting
Research Site
Niagara Falls, Ontario L2H 1H5
CanadaActive - Recruiting
Research Site
Ottawa, Ontario K1G 6C6
CanadaActive - Recruiting
Research Site
Windsor, Ontario N8X 2G1
CanadaActive - Recruiting
Research Site
Montreal, Quebec H4A 3T2
CanadaSite Not Available
Research Site
Beijing, 100020
ChinaActive - Recruiting
Research Site
Changsha, 430033
ChinaActive - Recruiting
Research Site
Guangzhou, 510515
ChinaActive - Recruiting
Research Site
Hangzhou, 310052
ChinaActive - Recruiting
Research Site
Nanjing, 2100008
ChinaActive - Recruiting
Research Site
Shanghai, 200025
ChinaActive - Recruiting
Research Site
Shenyang, 110004
ChinaActive - Recruiting
Research Site
Tianjin, 300050
ChinaActive - Recruiting
Research Site
Wuhan, 430022
ChinaActive - Recruiting
Research Site
Zhengzhou, 450052
ChinaActive - Recruiting
Research Site
Brno, 625 00
CzechiaActive - Recruiting
Research Site
Hradec Kralove, 500 12
CzechiaActive - Recruiting
Research Site
Praha, 190 00
CzechiaCompleted
Research Site
Aalborg, 9000
DenmarkActive - Recruiting
Research Site
Køge, 4600
DenmarkActive - Recruiting
Research Site
Odense, 5000
DenmarkActive - Recruiting
Research Site
Helsinki, 00100
FinlandSite Not Available
Research Site
Hämeenlinna, 13530
FinlandSite Not Available
Research Site
Kuopio, 70210
FinlandSite Not Available
Research Site
Turku, 20520
FinlandSite Not Available
Research Site
Frankfurt, 60590
GermanySite Not Available
Research Site
Landsberg, 86899
GermanySite Not Available
Research Site
München, 81675
GermanyActive - Recruiting
Research Site
Athens, 11521
GreeceActive - Recruiting
Research Site
Thessaloniki, 54642
GreeceActive - Recruiting
Research Site
Haifa, 31048
IsraelSite Not Available
Research Site
Holon, 58100
IsraelActive - Recruiting
Research Site
Jerusalem, 91120
IsraelActive - Recruiting
Research Site
Petah Tikva, 4920235
IsraelActive - Recruiting
Research Site
Tel Aviv, 62748
IsraelActive - Recruiting
Research Site
Tel Hashomer, 52620
IsraelActive - Recruiting
Research Site
Bologna, 40138
ItalyTerminated
Research Site
Milano, 20162
ItalyActive - Recruiting
Research Site
Napoli, 80131
ItalySite Not Available
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Pisa, 56124
ItalyActive - Recruiting
Research Site
Roma, 00168
ItalyActive - Recruiting
Research Site
Rozzano, 20089
ItalyActive - Recruiting
Research Site
Verona, 37134
ItalyActive - Recruiting
Research Site
Akita-shi, 010-8543
JapanActive - Recruiting
Research Site
Fukuoka-shi, 812-8582
JapanActive - Recruiting
Research Site
Himeji, 670-8560
JapanActive - Recruiting
Research Site
Hiroshima-shi, 734-8551
JapanActive - Recruiting
Research Site
Isehara-shi, 259-1193
JapanActive - Recruiting
Research Site
Kawasaki-shi, 211-0063
JapanActive - Recruiting
Research Site
Kitakyushu-shi, 802-0077
JapanActive - Recruiting
Research Site
Maebashi-shi, 371-8511
JapanActive - Recruiting
Research Site
Minato-ku, 105-8471
JapanSite Not Available
Research Site
Osaka, 545-8586
JapanActive - Recruiting
Research Site
Shinjuku-ku, 162-8655
JapanActive - Recruiting
Research Site
Yamagata-shi, 990-9585
JapanActive - Recruiting
Research Site
Amsterdam, 1081 HV
NetherlandsActive - Recruiting
Research Site
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Research Site
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Research Site
Christchurch, 8011
New ZealandActive - Recruiting
Research Site
Grafton, 1023
New ZealandSite Not Available
Research Site
Hamilton, 3204
New ZealandActive - Recruiting
Research Site
Newtown, 6021
New ZealandActive - Recruiting
Research Site
Otahuhu, 2025
New ZealandActive - Recruiting
Research Site
Wellington, 2820
New ZealandSite Not Available
Research Site
Lørenskog, N-1478
NorwayActive - Recruiting
Research Site
Oslo, 0450
NorwayActive - Recruiting
Research Site
Tromsø, N-9038
NorwayActive - Recruiting
Research Site
Ålesund, 6026
NorwayActive - Recruiting
Research Site
Kosice, 04013
SlovakiaActive - Recruiting
Research Site
Martin, 03601
SlovakiaActive - Recruiting
Research Site
Barcelona, 08036
SpainActive - Recruiting
Research Site
Bilbao (Vizcaya), 48013
SpainSite Not Available
Research Site
Madrid, 28007
SpainActive - Recruiting
Research Site
Pamplona, 31008
SpainActive - Recruiting
Research Site
Sevilla, 41013
SpainActive - Recruiting
Research Site
Tomelloso, 13700
SpainActive - Recruiting
Research Site
Stockholm, 171 76
SwedenActive - Recruiting
Research Site
Trollhättan, 461 73
SwedenActive - Recruiting
Research Site
Uppsala, 751 85
SwedenActive - Recruiting
Research Site
Brighton, BN2 1ES
United KingdomSite Not Available
Research Site
London, WC1N 3JH
United KingdomActive - Recruiting
Research Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Research Site
Little Rock, Arkansas 72202
United StatesActive - Recruiting
Research Site
Los Angeles, California 90033
United StatesActive - Recruiting
Research Site
Aurora, Colorado 80045
United StatesActive - Recruiting
Research Site
Inverness, Florida 34452
United StatesCompleted
Research Site
Jacksonville, Florida 32256
United StatesActive - Recruiting
Research Site
Saint Augustine, Florida 32086
United StatesCompleted
Research Site
Atlanta, Georgia 30322
United StatesSite Not Available
Research Site
Chicago, Illinois 60611
United StatesSite Not Available
Research Site
Normal, Illinois 61761
United StatesActive - Recruiting
Research Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Research Site
Topeka, Kansas 66606
United StatesActive - Recruiting
Research Site
White Marsh, Maryland 21162
United StatesActive - Recruiting
Research Site
Boston, Massachusetts 02111
United StatesActive - Recruiting
Research Site
Chesterfield, Michigan 48047
United StatesActive - Recruiting
Research Site
Lincoln, Nebraska 68503
United StatesActive - Recruiting
Research Site
Ocean City, New Jersey 07712
United StatesActive - Recruiting
Research Site
Teaneck, New Jersey 07666
United StatesSite Not Available
Research Site
Brooklyn, New York 11235
United StatesActive - Recruiting
Research Site
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Research Site
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Smithfield, Pennsylvania 15478
United StatesActive - Recruiting
Research Site
Greenville, South Carolina 29615
United StatesSite Not Available
Research Site
Nashville, Tennessee 37232
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Salt Lake City, Utah 84132
United StatesActive - Recruiting
Research Site
Charlottesville, Virginia 22908
United StatesSite Not Available
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