A multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 2 trial to evaluate the efficacy and safety of BP1.7881 in adult patients with eosinophilic esophagitis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bioprojet Pharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

29 Nov 2024 → ongoing

Decision date (initial)

2024-06-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bioprojet Pharma

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of this trial is to evaluate the histological changes in eosinophil infiltration of the esophageal tissue.

Secondary objectives 1

1. To evaluate the safety, tolerability, and efficacy of BP1.7881 in adult patients with eosinophilic esophagitis

Conditions and MedDRA coding

Eosinophilic esophagitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written informed consent obtained prior to any trial-related procedures.
2. Male or female ≥18 years old.
3. Presence of EoE associated symptoms at least during the last 4 weeks prior to screening (e.g., symptoms may include dysphagia which require liquids, coughing or gagging, vomiting, or medical attention to obtain relief).
4. A diagnosis of EoE confirmed at screening.
5. To the opinion of the investigator the patient will be compliant to carry out the trial procedures, including both esophagogastroduodenoscopies with biopsies.
6. Patients must have a cooperative attitude and be able to comply with the entire trial requirements and procedures (e.g., trial-related questionnaire, drug compliance, not use prohibited concomitant medications).
7. Female patients: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential (WOCBP, defined as all women physiologically capable of becoming pregnant) using a highly effective method of contraception* for the duration of the trial and for one month after stopping the investigational medication.
8. If required, patient must be insured by appropriate national health insurance system.

Exclusion criteria 19

1. Patient with any of the following disease: documented gastroesophageal reflux disease (note: reflux associated with EoE is not exclusionary), recurrent vomiting due to causes other than EoE, parasitic and fungal infections of the gastrointestinal tract, congenital esophageal rings, Crohn’s disease, periarteritis, allergic vasculitis, drug injury, connective tissue diseases, bullous pemphigoid, pemphigoid vegetans, graft-versus-host disease, achalasia, celiac disease, vasculitis, carcinoma of the esophagus.
2. Critical esophageal stricture or stricture not allowing the passage of a diagnostic upper endoscope (e.g., with an insertion tube diameter > 9mm).
3. Has a history of esophageal surgery or an esophageal dilation
4. Initiation or change of a food-elimination diet or introduction of a previously eliminated food group in the 6 weeks prior to screening. Patient on a food-elimination diet must remain on the same diet throughout the study period.
5. Contraindicated for esophageal biopsy for any reason (e.g., presence of varices at endoscopy).
6. Current evidence of oropharyngeal or esophageal candidiasis or active infection with Helicobacter pylori.
7. Commencement, cessation, or modification of the dosage schedule for allergen immunotherapy (oral or sublingual); participants maintaining a consistent dosage of these treatments for a minimum of one year before screening are eligible for inclusion in the study. However, they are prohibited from altering the dosage throughout the course of the study.Use of systemic corticosteroids within 12 weeks or swallowed corticosteroids within 8 weeks prior to screening.
8. Use of systemic immunosuppressive or immunomodulating drugs within 6 months prior to screening (e.g., Dupilumab, Mepolizumab, Reslizumab, or other interleukin inhibitors, prostaglandin D2 receptor antagonist, montelukast, purine analogues, anti-TNF therapy, cromolyn, anti-IgE monoclonal antibody).
9. Female patient: pregnant or lactating woman. [Pregnancy is confirmed by a positive serum human chorionic gonadotrophin laboratory test (> 5mIU/mL). Serum pregnancy test will be done at screening and urine test at randomization]
10. History of significant cardiovascular disease, particularly recent history of myocardial infarction or unstable coronary artery disease, arrhythmias, congestive heart failure, uncontrolled arterial hypertension. Patient with a known history of long QT syndrome with or without history of syncope.
11. Patient with a clinically significant deviation(s) from normal on 12-lead ECG that results in an active medical problem, as determined by the Investigator at screening or has a corrected QT interval using Fridericia’s formula (QTcF) ≥450 msec for males or ≥470 msec for females.
12. Patient with unstable concurrent disease including: uncontrolled hyperthyroidism or other endocrine disease, uncontrolled gastrointestinal disease (e.g. active peptic ulcer), uncontrolled hematological disease, uncontrolled autoimmune disorders, or other that might affect the patient’s safety and/or interfere with the conduct of the study according to the Investigator’s judgement.
13. Patient with known or history of malignancy within the past 5 years with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
14. Established diagnosis of human immunodeficiency virus (HIV), hepatitis B viral infection or is positive for hepatitis surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening or established diagnosis of hepatitis C viral infection or is positive for hepatitis C antibody at the time of screening visit.
15. Patient who has a laboratory abnormality at screening.
16. History of hypersensitivity to any of the study drug constituents.
17. Sexually active male unless he uses a condom during intercourse while taking drug and for 90 days after stopping investigational medication.
18. Current or recent history (less than one year) of alcohol or drug abuse.
19. Patient having received any other investigational drug within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the previous investigational drug).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf at week 12.

Secondary endpoints 5

1. Change in total EoE-Dysphagia Assessment Questionnaire (EDAQ) score from baseline to week 12.
2. Change inEosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) from baseline to week 12.
3. Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf).
4. Change in EoE Grade Score from the Histology Scoring System (EoE-HSS) from baseline to week 12.
5. Change in EoE Stage Score from the EoE-HSS from baseline to week 12.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioprojet Pharma

Sponsor organisation

Bioprojet Pharma

Address

9 Rue Rameau

City

Paris

Postcode

75002

Country

France

Scientific contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory affairs manager

Public contact point

Organisation

Bioprojet Pharma

Contact name

Regulatory affairs manager

Locations

2 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications