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A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease

NCT ID: NCT07298421

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-29

Study Completion Date

2031-05-29

Brief Summary

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This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).

Detailed Description

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Conditions

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Moderately to Severely Active Crohns Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Afimkibart Dose A

Participants will receive Afimkibart intravenously (IV) followed by Afimkibart subcutaneous (SC) injection.

Group Type EXPERIMENTAL

Afimkibart

Intervention Type DRUG

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Afimkibart Dose B

Participants will receive Afimkibart IV followed by Afimkibart SC.

Group Type EXPERIMENTAL

Afimkibart

Intervention Type DRUG

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Interventions

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Afimkibart

Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.

Intervention Type DRUG

Other Intervention Names

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RO7790121 PF-06480605 RVT-3101

Eligibility Criteria

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Inclusion Criteria

* Body weight \>= 10 kilogram (kg)
* Active CD confirmed by endoscopy (ileocolonoscopy)
* Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \>=6 (or \>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy
* Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)

Exclusion Criteria

* Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)
* History of \>= 3 bowel resections: \> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum
* Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.
* Symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* Presence of abdominal or perianal abscess
* Current diagnosis or suspicion of primary sclerosing cholangitis
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Central Contacts

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Reference Study ID Number: CP45906 https://forpatients.roche.com/

Role: CONTACT

Phone: 888-662-6728 (U.S. and Canada)

Email: [email protected]

Other Identifiers

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CP45906

Identifier Type: -

Identifier Source: org_study_id

2025-523318-96-00

Identifier Type: CTIS

Identifier Source: secondary_id