Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Study Purpose
A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years - 80 Years |
| Gender | All |
Inclusion Criteria:
1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent. 2. Weight ≥ 40 kg at Visit 1. 3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE. 4. 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 in the throat) per week in the 4 weeks prior to Visit 1. 5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups). 6. May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change background medication or dosage unless medically indicated, during the screening/run-in and treatment period. 7. Participants currently on leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally, must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1). 8. If a medication for EoE (for example PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of 4 months or 5 half-lives prior to Visit 1, whichever is longer. 9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.Exclusion Criteria:
1. 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 significant gastrointestinal conditions as per Investigator discretion. 2. Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening. 3. 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. 4. Hypereosinophilic syndrome. 5. EGPA vasculitis. 6. Esophageal dilation performed within 8 weeks prior to screening.Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05583227 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AstraZeneca |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Slovakia, Spain, Sweden, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Eosinophilic Esophagitis |
| Study Website: | View Trial Website |
The study consists of a screening period of 2 to 8 weeks and a 52-week randomized double-blind placebo-controlled treatment period. After completion of the treatment period, participants will be eligible to participate in an optional active treatment extension period (lasting for 24 weeks), followed by a 12-week off-treatment safety follow-up period. Participants who will not participate in the extension period will participate in a 12-week off-treatment safety follow-up period following completion of the 52-week treatment period. This study will randomize approximately 360 participants. The participants will be randomized at 1:1:1 ratio to the 3 treatment arms.
Arms
Experimental: Tezepelumab Low Dose
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Experimental: Tezepelumab High Dose
Tezepelumab subcutaneous injections, in accessorised pre-filled syringes
Placebo Comparator: Placebo
Placebo subcutaneous injections, in accessorised pre-filled syringes
Interventions
Biological: - Tezepelumab
Tezepelumab subcutaneous injection
Biological: - Tezepelumab
Tezepelumab subcutaneous injection
Other: - Placebo
Placebo subcutaneous injection
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Research Site
Phoenix 5308655, Arizona 5551752, 85016
Status
Address
Research Site
Little Rock 4119403, Arkansas 4099753, 72202
Status
Address
Research Site
Los Angeles 5368361, California 5332921, 90033
Status
Address
Research Site
Aurora 5412347, Colorado 5417618, 80045
Status
Address
Research Site
Inverness 4159786, Florida 4155751, 34452
Status
Address
Research Site
Jacksonville 4160021, Florida 4155751, 32256
Status
Address
Research Site
Saint Augustine 4170894, Florida 4155751, 32086
Status
Address
Research Site
Normal 4903780, Illinois 4896861, 61761
Status
Address
Research Site
Iowa City 4862034, Iowa 4862182, 52242
Status
Address
Research Site
Topeka 4280539, Kansas 4273857, 66606
Status
Address
Research Site
White Marsh 4373426, Maryland 4361885, 21162
Status
Address
Research Site
Boston 4930956, Massachusetts 6254926, 02111
Status
Address
Research Site
Chesterfield 4988681, Michigan 5001836, 48047
Status
Address
Research Site
Lincoln 5072006, Nebraska 5073708, 68503
Status
Address
Research Site
Ocean City 4503351, New Jersey 5101760, 07712
Status
Address
Research Site
Brooklyn 5110302, New York 5128638, 11235
Status
Address
Research Site
Chapel Hill 4460162, North Carolina 4482348, 27599
Status
Address
Research Site
Cincinnati 4508722, Ohio 5165418, 45229
Status
Address
Research Site
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Address
Research Site
Smithfield 4561301, Pennsylvania 6254927, 15478
Status
Address
Research Site
Nashville 4644585, Tennessee 4662168, 37232
Status
Address
Research Site
Houston 4699066, Texas 4736286, 77030
Status
Address
Research Site
Salt Lake City 5780993, Utah 5549030, 84107
Status
Address
Research Site
Salt Lake City 5780993, Utah 5549030, 84132
International Sites
Status
Address
Research Site
Elizabeth Vale 9973185, , 5112
Status
Address
Research Site
Kogarah 2161185, , 2217
Status
Address
Research Site
South Brisbane 2207259, , QL 4101
Status
Address
Research Site
Woolloongabba 6943568, , 4102
Status
Address
Research Site
Vienna 2761369, , 1090
Status
Address
Research Site
Wels-Grieskirchen, , 4600
Status
Address
Research Site
Bruges 2800931, , 8310
Status
Address
Research Site
Edegem 2799007, , 2650
Status
Address
Research Site
Ghent 2797656, , 9000
Status
Address
Research Site
Leuven 2792482, , 3000
Status
Address
Research Site
Botucatu 3469136, , 18618-687
Status
Address
Research Site
Brasília 3469058, , 71681-603
Status
Address
Research Site
Caxias do Sul 3466537, , 95070-560
Status
Address
Research Site
Curitiba 3464975, , 80250-060
Status
Address
Research Site
Curitiba 3464975, , 80440-220
Status
Address
Research Site
Porto Alegre 3452925, , 90035-903
Status
Address
Research Site
São José do Rio Preto 3448639, , 15090-000
Status
Address
Research Site
São Paulo 3448439, , 05.403-010
Status
Address
Research Site
Hamilton 5969782, Ontario 6093943, L8S 1G5
Status
Address
Research Site
London 6058560, Ontario 6093943, N6A 5W9
Status
Address
Research Site
Niagara Falls 6087892, Ontario 6093943, L2H 1H5
Status
Address
Research Site
Ottawa 6094817, Ontario 6093943, K1G 6C6
Status
Address
Research Site
Windsor 6182962, Ontario 6093943, N8X 2G1
Status
Address
Research Site
Beijing 1816670, , 100020
Status
Address
Research Site
Beijing 1816670, , 100050
Status
Address
Research Site
Changsha 1815577, , 430033
Status
Address
Research Site
Guangzhou 1809858, , 510080
Status
Address
Research Site
Guangzhou 1809858, , 510515
Status
Address
Research Site
Hangzhou 1808926, , 310052
Status
Address
Research Site
Nanjing 1799962, , 2100008
Status
Address
Research Site
Shanghai 1796236, , 200000
Status
Address
Research Site
Shanghai 1796236, , 200025
Status
Address
Research Site
Shenyang 2034937, , 110004
Status
Address
Research Site
Tianjin 1792947, , 300050
Status
Address
Research Site
Wuhan 1791247, , 430022
Status
Address
Research Site
Zhengzhou 1784658, , 450052
Status
Address
Research Site
Brno 3078610, , 625 00
Status
Address
Research Site
Hradec Králové 3074967, , 500 12
Status
Address
Research Site
Prague 3067696, , 190 00
Status
Address
Research Site
Aalborg 2624886, , 9000
Status
Address
Research Site
Køge 2618415, , 4600
Status
Address
Research Site
Odense 2615876, , 5000
Status
Address
Research Site
Helsinki 658225, , 00290
Status
Address
Research Site
München 2867711, , 81675
Status
Address
Research Site
Athens 264371, , 11521
Status
Address
Research Site
Athens 264371, , 11527, GR
Status
Address
Research Site
Athens 264371, , 11527
Status
Address
Research Site
Athens 264371, , 12462
Status
Address
Research Site
Thessaloniki 734077, , 56429
Status
Address
Research Site
Holon 294751, , 58100
Status
Address
Research Site
Jerusalem 281184, , 91120
Status
Address
Research Site
Petah Tikva 293918, , 4920235
Status
Address
Research Site
Petah Tikva 293918, , 4941492
Status
Address
Research Site
Tel Aviv 293397, , 62748
Status
Address
Research Site
Tel Aviv 293397, , 6423906
Status
Address
Research Site
Tel Litwinsky 293361, , 52620
Status
Address
Research Site
Bologna 3181928, , 40138
Status
Address
Research Site
Milan 6951411, , 20162
Status
Address
Research Site
Napoli 9031661, , 80131
Status
Address
Research Site
Padua 3171728, , 35128
Status
Address
Research Site
Pisa 3170647, , 56124
Status
Address
Research Site
Roma 8957247, , 00161
Status
Address
Research Site
Roma 8957247, , 00168
Status
Address
Research Site
Rozzano 3168837, , 20089
Status
Address
Research Site
Verona 3164527, , 37134
Status
Address
Research Site
Akita 2113126, , 010-8543
Status
Address
Research Site
Fukuoka 1863967, , 812-8582
Status
Address
Research Site
Himeji 1862627, , 670-8560
Status
Address
Research Site
Hiroshima 1862415, , 734-8551
Status
Address
Research Site
Isehara-shi, , 259-1193
Status
Address
Research Site
Kawasaki-shi, , 211-0063
Status
Address
Research Site
Kitakyushu-shi, , 802-0077
Status
Address
Research Site
Maebashi 1857843, , 371-8511
Status
Address
Research Site
Minatoku 11191118, , 108-8329
Status
Address
Research Site
Osaka 1853909, , 545-8586
Status
Address
Research Site
Shinjuku-ku, , 160-8582
Status
Address
Research Site
Shinjuku-ku, , 162-8655
Status
Address
Research Site
Yamagata 2110556, , 990-9585
Status
Address
Research Site
Amsterdam 2759794, , 1081 HV
Status
Address
Research Site
Nijmegen 2750053, , 6525 GA
Status
Address
Research Site
Rotterdam 2747891, , 3015 GD
Status
Address
Research Site
Christchurch 2192362, , 8011
Status
Address
Research Site
Hamilton 2190324, , 3204
Status
Address
Research Site
Newtown 6244789, , 6021
Status
Address
Research Site
Otahuhu 6232009, , 2025
Status
Address
Research Site
Ålesund 3163392, , 6026
Status
Address
Research Site
Lørenskog, , 1478
Status
Address
Research Site
Lørenskog, , N-1478
Status
Address
Research Site
Oslo 3143244, , 0450
Status
Address
Research Site
Tromsø 3133895, , N-9038
Status
Address
Research Site
Košice 724443, , 04013
Status
Address
Research Site
Barcelona 3128760, , 08035
Status
Address
Research Site
Barcelona 3128760, , 08036
Status
Address
Research Site
Madrid 3117735, , 28006
Status
Address
Research Site
Madrid 3117735, , 28007
Status
Address
Research Site
Madrid 3117735, , 28031
Status
Address
Research Site
Pamplona 3114472, , 31008
Status
Address
Research Site
Seville 2510911, , 41009
Status
Address
Research Site
Seville 2510911, , 41013
Status
Address
Research Site
Tomelloso 2510392, , 13700
Status
Address
Research Site
Stockholm 2673730, , 171 76
Status
Address
Research Site
Trollhättan 2667303, , 461 73
Status
Address
Research Site
Uppsala 2666199, , 751 85
Status
Address
Research Site
London 2643743, , SW17 0QT
Status
Address
Research Site
London 2643743, , WC1N 3JH
