[M23-703] A Study to Assess Adverse Events and Change in Disease Activity from Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants with Active Ulcerative Colitis

[M23-703] A Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Lutikizumab for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240064

Enrollment

Registered

2024-05-07

Start date

2024-08-01

Completion date

Unknown

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to luti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available. - Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review). - Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.

Exclusion criteria

Exclusion criteria: - Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified. - Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. - Prior exposure to adalimumab (including biosimilars). Note: Subject may be enrolled if he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.

Design outcomes

Primary

Measure	Time frame
Outcome Measure: Percentage of Participants who Achieve Endoscopic Improvement Measure Description: Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). Time Frame: Week 12 Outcome Measure: Number of Participants with Adverse Events (AEs) Measure Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Time Frame: Up to approximately Week 64	—

Measure

Time frame

Outcome Measure: Percentage of Participants who Achieve Endoscopic Improvement Measure Description: Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). Time Frame: Week 12 Outcome Measure: Number of Participants with Adverse Events (AEs) Measure Description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. Time Frame: Up to approximately Week 64

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, Norway, Poland, Puerto Rico, Serbia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United States of America

Contacts

Public ContactContact for Patients and HCP

AbbVie GK

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026