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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

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
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
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital /ID# 259482 - Woodville South
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
North Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Croatia
State/province [13] 0 0
Osjecko-baranjska Zupanija
Country [14] 0 0
Israel
State/province [14] 0 0
HaDarom
Country [15] 0 0
Israel
State/province [15] 0 0
HaMerkaz
Country [16] 0 0
Israel
State/province [16] 0 0
Tel-Aviv
Country [17] 0 0
Israel
State/province [17] 0 0
Yerushalayim
Country [18] 0 0
Israel
State/province [18] 0 0
Haifa
Country [19] 0 0
Japan
State/province [19] 0 0
Aichi
Country [20] 0 0
Japan
State/province [20] 0 0
Chiba
Country [21] 0 0
Japan
State/province [21] 0 0
Fukushima
Country [22] 0 0
Japan
State/province [22] 0 0
Gifu
Country [23] 0 0
Japan
State/province [23] 0 0
Hiroshima
Country [24] 0 0
Japan
State/province [24] 0 0
Hyogo
Country [25] 0 0
Japan
State/province [25] 0 0
Kagoshima
Country [26] 0 0
Japan
State/province [26] 0 0
Osaka
Country [27] 0 0
Japan
State/province [27] 0 0
Saga
Country [28] 0 0
Japan
State/province [28] 0 0
Saitama
Country [29] 0 0
Japan
State/province [29] 0 0
Shizuoka
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul Teugbyeolsi
Country [32] 0 0
New Zealand
State/province [32] 0 0
Waikato
Country [33] 0 0
Puerto Rico
State/province [33] 0 0
Bayamon
Country [34] 0 0
South Africa
State/province [34] 0 0
Gauteng
Country [35] 0 0
Switzerland
State/province [35] 0 0
Bern
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei
Country [37] 0 0
Taiwan
State/province [37] 0 0
Hsinchu City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taichung

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06257875