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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257875
• Other study ID #: M23-703
• Secondary ID: 2023-505678-14-0
• Status: Recruiting
• Phase: Phase 2
• Start date: March 23, 2024
• Est. completion date: April 23, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed.

Lutikizumab is an investigational product being developed for the treatment of UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. 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 lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide.

In the Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab for 12 weeks. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab until Week 52. Participants who do not respond to treatment will receive open-label SC lutikizumab until Week 52.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 23, 2027
• Est. primary completion date: April 23, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Lutikizumab Matching Placebo
SC Injection
• Lutikizumab Matching Placebo
IV Infusion
• Adalimumab Matching Placebo
SC Injection
• Lutikizumab
Subcutaneous (SC) Injection
• Lutikizumab
Intravenous (IV) Infusion
• Adalimumab
SC Injection

Locations

Country	Name	City	State
Japan	Gamagori City Hospital /ID# 260682	Gamagori-shi	Aichi
Japan	Kagoshima IBD Gastroenterology Clinic /ID# 259603	Kagoshima-shi	Kagoshima
Japan	Tsujinaka Hospital Kashiwanoha /ID# 258548	Kashiwa-shi	Chiba
Japan	Aoyama Clinic /ID# 259587	Kobe-shi	Hyogo
Japan	Kinshukai Infusion Clinic /ID# 259588	Osaka-shi	Osaka
United States	DJL Clinical Research, PLLC /ID# 259465	Charlotte	North Carolina
United States	Clin Res Inst of Michigan, LLC /ID# 258386	Chesterfield	Michigan
United States	Clin Res Inst of Michigan, LLC /ID# 259267	Chesterfield	Michigan
United States	Gastro SB /ID# 258331	Chula Vista	California
United States	Research Associates of South Florida, LLC /ID# 259813	Coral Gables	Florida
United States	Plains Clinical Research Center, LLC /ID# 258502	Fargo	North Dakota
United States	BioStar Clinical Research Group - Houston - Katy Freeway /ID# 261164	Houston	Texas
United States	Newport Huntington Medical Group /ID# 258371	Huntington Beach	California
United States	Auzmer Research /ID# 260940	Lakeland	Florida
United States	Om Research LLC /ID# 261383	Lancaster	California
United States	Gastroenterology Associates of Central Georgia, LLC /ID# 258359	Macon	Georgia
United States	Atlantic Medical Research /ID# 258507	Margate	Florida
United States	Homestead Associates in Research /ID# 260392	Miami	Florida
United States	Wisconsin Center for Advanced Research /ID# 258949	Milwaukee	Wisconsin
United States	Digestive Disease Specialists /ID# 258499	Oklahoma City	Oklahoma
United States	Gastroenterology Consultants, P.C /ID# 258352	Roswell	Georgia
United States	Clinical Associates in Research Therapeutics of America, LLC /ID# 258403	San Antonio	Texas
United States	Southern Star Research Institute, LLC /ID# 258347	San Antonio	Texas
United States	Louisiana Research Center, LLC /ID# 258330	Shreveport	Louisiana
United States	Tyler Research Institute, LLC /ID# 258383	Tyler	Texas
United States	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 258493	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Achieve Endoscopic Improvement	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).	Week 12
Primary	Number of Participants with Adverse Events (AEs)	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.	Up to approximately Week 64
Secondary	Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS)	Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore <= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	Week 12
Secondary	Percentage of Participants who Achieve Clinical Response Per mMS	Clinical response per mMS is defined as decrease from baseline >=2 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease [spontaneous bleeding, ulceration]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.	Week 12
Secondary	Percentage of Participants who Achieve Endoscopic Remission	Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. 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).	Week 12

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