Study of Targeted Therapies for the Treatment of Adult Participants with Moderate to Severe Crohn’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

21 Nov 2024 → ongoing

Decision date (initial)

2024-11-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The objective is to evaluate the safety and efficacy and to assess the mechanistic profile of studied targeted therapies (TaTs)

Conditions and MedDRA coding

Moderate to Severe Crohn’s Disease

Regulatory references

Scientific advice from competent authorities

Central Committee On Research Involving Human Subjects, European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adults 18 to ≤ 75 years old (subjects must also meet the legal age of majority per local law).
2. Subjects' body weight must be ≥ 40 kg at Baseline.
3. Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
4. CDAI ≥ 220 at Baseline.
5. Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
6. Subjects must demonstrate intolerance or inadequate response to 1 or more of the following categories of drugs: oral locally acting steroids, systemic steroids (prednisone or equivalent), immunomodulators, and/or TaTs including biologics (e.g., infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or biosimilars) and/or small molecules, e.g., upadacitinib, and/or inadequate response to p19 inhibitors (anti-IL-23 mAbs). For Denmark only: Subjects must demonstrate intolerance or inadequate response to TATs

Exclusion criteria 3

1. Subjects who demonstrated intolerance to p19 inhibitors, including risankizumab.
2. Subject who received: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, including biosimilars within 8 weeks prior to Baseline, or ustekinumab (including biosimilars), risankizumab within 12 weeks prior to Baseline, or upadacitinib within 2 weeks prior to Baseline,any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
3. Subject who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as::abscess (abdominal or perianal); symptomatic bowel strictures; > 2 resected segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon and sigmoid, and rectum; previous small bowel resection with combined resected length of > 100 centimeters; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study;Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Achievement of endoscopic remission at Week 12.

Secondary endpoints 3

1. Clinical remission per Crohn's disease activity index (CDAI) at Week 12.
2. Clinical remission per stool frequency (SF)/abdominal pain score (APS) at Week 12.
3. Endoscopic response at Week 12.

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 8

Locations

23 EU/EEA countries · 137 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 158 files

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

Application history

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