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A Study to Assess the Efficacy and Safety of Afimkibart for Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

ConditionModerately to Severely Active Ulcerative Colitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-80
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of UC.

Moderately to severely active UC assessed by modified Mayo Score (mMS).

Bodyweight >= 40 kilogram (kg).

Up to date with colorectal cancer (CRC) screening performed according to local standards.

Disqualifiers

Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).

Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.

Presence of an ostomy or ileoanal pouch.

Current diagnosis or suspicion of primary sclerosing cholangitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Afimkibart

    Drug

    Afimkibart will be administered as SC injection.

  • Placebo

    Drug

    Placebo will be administered as SC injection.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: AfimkibartExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Clinical Remission

Time frame
At Week 12

Secondary outcomes

1

Change From Baseline in Stool Frequency Subscore (SFS)

The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal)

Time frame
From Baseline up to Week 12
2

Change From Baseline in Rectal Bleeding Subscore (RBS)

The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed)

Time frame
From Baseline up to Week 12
3

Percentage of Participants With Symptomatic Response

Time frame
At Week 4
4

Percentage of Participants With Endoscopic Improvement

Time frame
At Week 12 and Week 24

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Chugai Pharmaceutical

Collaborator

Pfizer

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: