A trial to learn how safe AZD7798 is and how well it works in adults with ileal Crohn’s disease who have an ileostomy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Dec 2024 → ongoing

Decision date (initial)

2024-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Others, Safety

To evaluate the safety and tolerability of repeated doses of AZD7798 in the induction period

Secondary objectives 3

1. To evaluate the safety and tolerability of repeated doses of AZD7798 in the open label maintenance period.
2. To evaluate the efficacy of AZD7798 treatment on small bowel endoscopic healing in the induction period.
3. To evaluate the pharmacokinetics and immunogenicity of AZD7798.

Conditions and MedDRA coding

Crohn’s Disease and an Ileostomy

Study design 2 periods

Regulatory references

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 18 to 80 years of age inclusive, at the time of signing the ICF.
2. Diagnosis of Crohn’s disease established with clinical, imaging, endoscopic, and/or histopathologic evidence.
3. Ileostomy for at least 3 months.
4. Prior to screening endoscopy, clinical suspicion of active ileal inflammation based on at least one of the following: previous endoscopy, imaging (CT, MRI, IUS), or FCP above upper reference limit.
5. Active ileal Crohn’s disease as determined by active intestinal mucosal inflammation, as demonstrated on video recorded ileoscopy performed during the screening period and scored by a blinded central reader with agreement on the SES CD ≥ 4 of the ileal segment proximal to the stoma. Participants with inflammation in additional intestinal segments are not excluded.

Exclusion criteria 9

1. Concomitant additional gastrointestinal luminal inflammatory diseases including, but not limited to, infectious enteritis, ischaemic bowel, inflammation, and strictures caused by previousradiation therapy.
2. Strictures/stenoses preventing passage of endoscope throughout the specified segment (up to 25 cm of ileum)
3. Short bowel syndrome.
4. Within 3 months prior to screening: -Diagnosis of peritonitis or need treatment of peritonitis -Bowel perforation or evidence of obstruction
5. All intrabdominal, cutaneous and perianal/perirectal abscessesand fistulae are excluded with exception of: cutaneous and perianal/perirectal abscesses which are adequately drained 4 weeks prior to randomisation, and intraabdominal fistulae between bowel segments only without complications
6. Ongoing or expected nutritional dependency on total enteral or parenteral nutrition during study (partial nutrition acceptable).
7. In patients with any remaining colon and/or rectum, evidence of an increased risk of colorectal cancer, including: (a) Adenomatous colonic/rectal polyps that have not been removed (b) Intestinal dysplasia (c) Not undertaking appropriate surveillance, if indicated, for colorectal dysplasia/malignancy
8. Reversal of ileostomy or formation of J-pouch planned prior to end of study period.
9. High-output stoma (eg, > 2000 mL/24 hours) associated with volume depletion and/or electrolyte disturbance to the extent that,in the opinion of the Investigator, it may put the patient at undue risk because of participation in the study, or impact their ability to participate in the study or interfere with the interpretation of study data.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs.

Secondary endpoints 3

1. Safety and tolerability evaluations using AEs, clinical laboratory assessments, vital sign measures, and 12 lead ECGs since week12 to week 52.
2. a) Change from baseline in endoscopic score (SES CD using endoscopic assessment) at Week 12. b) Change from baseline in endoscopic score (MM SES-CD) at Week 12. c) Endoscopic response (≥ 50% decrease from baseline in SES-CD total score) at Week 12. d) Endoscopic remission (SES-CD total score < 4 and at least 2‑point reduction from baseline with no subscore > 1 in any individual variable) at Week 12.
3. a) Serum AZD7798 concentration. b) Incidence and titre of ADA response

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

5 EU/EEA countries · 14 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 28 files

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

Application history

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