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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06257875




Registration number
NCT06257875
Ethics application status
Date submitted
2/10/2023
Date registered
14/02/2024
Date last updated
5/11/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2023-505678-14-00
Secondary ID [2] 0 0
M23-703
Universal Trial Number (UTN)
Trial acronym
Horizon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lutikizumab Matching Placebo
Treatment: Drugs - Lutikizumab Matching Placebo
Treatment: Drugs - Adalimumab Matching Placebo
Treatment: Drugs - Lutikizumab
Treatment: Drugs - Lutikizumab
Treatment: Drugs - Adalimumab

Experimental: Induction Group 1 - Participants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Adalimumab placebo will be utilized to maintain the blind.

Experimental: Induction Group 2 - Participants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind.

Experimental: Induction Group 3 - Participants will receive adalimumab per label throughout induction. Lutikizumab placebo will be utilized to maintain the blind.

Experimental: Maintenance Group 1 - Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Adalimumab placebo will be utilized to maintain the blind.

Experimental: Maintenance Group 2 - Participants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period. Lutikizumab placebo and adalimumab placebo will be utilized to maintain the blind.

Experimental: Maintenance Adalimumab - Participants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period. Lutikizumab placebo will be utilized to maintain the blind.

Experimental: Maintenance Non-Responders - Participants who do not respond to study drug at the end of induction period will receive open label SC lutikizumab in the maintenance period.


Treatment: Drugs: Lutikizumab Matching Placebo
SC Injection

Treatment: Drugs: Lutikizumab Matching Placebo
IV Infusion

Treatment: Drugs: Adalimumab Matching Placebo
SC Injection

Treatment: Drugs: Lutikizumab
Subcutaneous (SC) Injection

Treatment: Drugs: Lutikizumab
Intravenous (IV) Infusion

Treatment: Drugs: Adalimumab
SC Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Achieve Endoscopic Improvement
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately Week 64
Secondary outcome [1] 0 0
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants who Achieve Clinical Response Per mMS
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Percentage of Participants who Achieve Endoscopic Remission
Timepoint [3] 0 0
Week 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/04/2027
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital /ID# 259482 - Woodville South
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne /ID# 259473 - Fitzroy Melbourne
Recruitment hospital [3] 0 0
Fiona Stanley Hospital /ID# 259480 - Murdoch
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Michigan
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New Mexico
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New York
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North Carolina
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North Dakota
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Oklahoma
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Texas
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West Virginia
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Wisconsin
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Belgium
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Bruxelles-Capitale
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Liege
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Belgium
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Gent
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Sofia
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Plovdiv
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Varna
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Ontario
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Grad Zagreb
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Croatia
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Rijeka
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Parnu
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Estonia
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Tartu
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France
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Pays-de-la-Loire
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Germany
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Baden-Wuerttemberg
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Germany
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Rheinland-Pfalz
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Germany
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Sachsen
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Hamburg
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Tolna
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Jablanicki Okrug
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Serbia
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Novi Sad
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Celje
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Ljubljana
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South Africa
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Gauteng
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Spain
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A Coruna
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Spain
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Navarra
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Switzerland
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Bern
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Taichung
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United Kingdom
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Cambridgeshire
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Oxfordshire
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Scotland
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06257875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06257875