A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)
- Conditions
- eosinophilic esophagitis (EoE) / chronic inflammatory disorder of the esophagus10017969
- Registration Number
- NL-OMON53940
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1. Participant must be 12 to 80 years of age inclusive, at the time of signing
the informed
consent/assent.The protocol indicated that subjects between 12 and 80 years old
can participate. In the Netherlands it is decided that only subjects between
the 18 and 80 can participate.
2. Weight >= 40 kg at Visit 1.
3. Previously established diagnosis of EoE by EGD and esophageal biopsy.
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 have been on stabilized diet for at least 8 weeks prior to Visit 1 and
be willing to remain on stabilized diet 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 medication for EoE, for example 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 should have previously documented standard of care treatment,
which could include PPI and/or STC and/or diet.
8. 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).
9. Participants with either of the following:
(a) 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.
(b) 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.
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, EGE, EG,
eosinophilic enteritis,colitis, diverticulitis, irritable bowel syndrome, or
other clinically significant gastrointestinal conditions as per investigator
discretion.
2. Eosinophilic granulomatosis with polyangiitis vasculitis.
3. Esophageal stricture that prevents the easy passage of a standard endoscope
or any critical esophageal stricture that requires dilation at screening.
4. Use of a feeding tube, or having a pattern of not eating solid food >= 3 days
of the week.
Solid food is defined as food that requires chewing before swallowing.
5. Hypereosinophilic syndrome
6. Esophageal dilation performed within 8 weeks prior to screening.
see section 5.2 of the protocol for a complete overview of all exclusion
criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To evaluate the effect of tezepelumab on the histologic response in adult and<br /><br>adolescent participants with symptomatic and histologically active EoE<br /><br>- To evaluate the effect of tezepelumab on symptom improvement in adult and<br /><br>adolescent participants with symptomatic and histologically active EoE</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key Secondary<br /><br>- To evaluate the effect of tezepelumab on the centrally-read EoE EREFS<br /><br>- To evaluate the effect of tezepelumab on the centrally-read EoE-HSS<br /><br>- To evaluate the long-term effect of tezepelumab on the histologic response<br /><br>- To evaluate the long-term effect of tezepelumab on symptom improvement<br /><br>- To evaluate the long-term effect of tezepelumab on the centrally-read EoE<br /><br>EREFS<br /><br>- To evaluate the effect of tezepelumab on achievement of clinico-histological<br /><br>remission<br /><br><br /><br>see table 7 for all Objectives and Endpoints</p><br>