Crohn's Disease: Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active 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] - Immune System Diseases [C20]

Trial duration

23 Jan 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2024-516023-13-00

ClinicalTrials.gov

NCT06063967

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy, Therapy

To assess the efficacy, safety, and tolerability of RZB SC induction treatment in comparison with placebo in subjects with moderately to severely active CD.

Conditions and MedDRA coding

Crohn's disease

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

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 the following link 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 5

1. Male or Female adult individuals, at least 18 years old (subjects must also meet the legal age of majority per local law) at the baseline visit.
2. Confirmed diagnosis of CD for at least 3 months prior to Baseline.
3. Moderately to severely active CD meeting the following disease activity criteria: -CDAI 220 to 450 at Baseline - Endoscopic evidence of mucosal inflammation as documented by a 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 confirmed by a blinded central reader.
4. Demonstrated intolerance or inadequate response to conventional and/or advanced therapies (biologics or targeted small molecules approved for CD)
5. If female, subject must meet the contraception recommendations

Exclusion criteria 5

1. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis.
2. Subjects with unstable doses of concomitant Crohn's disease therapy
3. Receipt of Crohn's disease approved biologic agent or advanced therapeutic agent, or any investigational drug within the period prior to Baseline as detailed in the protocol
4. Subjects with complications of CD (abscess, ostomy, ileoanal pouch, short bowel syndrome, etc. as detailed in the protocol
5. Prior exposure to p19 inhibitors (e.g.,risankizumab

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Achievement of CDAI clinical remission (defined as CDAI < 150) at Week 12
2. Achievement of endoscopic response (defined as decrease in SES-CD > 50% from baseline or for subjects with isolated ileal disease and a baseline SES-CD of 4, at least a 2-point reduction from baseline, as scored by blinded central reviewer) at Week 12

Secondary endpoints 5

1. Achievement of SF/APS Clinical remission (defined as average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline) at Week 12
2. Achievement of endoscopic remission (defined as SES-CD ≤ 4 and at least a 2-point reduction versus Baseline and no subscore greater than 1 in any individual variable, as scored by a blinded central reviewer) at Week 12
3. Achievement of ulcer-free endoscopy (defined as SES-CD ulcerated surface subscore of 0 in subjects with SESCD ulcerated surface subscore ≥ 1 at Baseline, as scored by a blinded central reviewer) at Week 12
4. Change from Baseline in FACIT-Fatigue at Week 12
5. Achievement of CR-100 CDAI clinical response (defined as at least a 100-point reduction from Baseline in CDAI) at Week 4

Investigational products

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

Test 1

Placebo 1

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 Contact

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Contact

Third parties 8

Locations

4 EU/EEA countries · 11 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 34 files

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

Application history

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