Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2023-505678-14-00
Query!
Secondary ID [2]
0
0
M23-703
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants who Achieve Endoscopic Improvement
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Week 12
Query!
Primary outcome [2]
0
0
Number of Participants with Adverse Events (AEs)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately Week 64
Query!
Secondary outcome [1]
0
0
Percentage of Participants who Achieve Clinical Remission Per Modified Mayo Score (mMS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
Percentage of Participants who Achieve Clinical Response Per mMS
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Percentage of Participants who Achieve Endoscopic Remission
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Week 12
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
23/03/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
23/04/2027
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
The Queen Elizabeth Hospital /ID# 259482 - Woodville South
Query!
Recruitment postcode(s) [1]
0
0
5011 - Woodville South
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Louisiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Dakota
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Wisconsin
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Ontario
Query!
Country [13]
0
0
Croatia
Query!
State/province [13]
0
0
Osjecko-baranjska Zupanija
Query!
Country [14]
0
0
Israel
Query!
State/province [14]
0
0
HaDarom
Query!
Country [15]
0
0
Israel
Query!
State/province [15]
0
0
HaMerkaz
Query!
Country [16]
0
0
Israel
Query!
State/province [16]
0
0
Tel-Aviv
Query!
Country [17]
0
0
Israel
Query!
State/province [17]
0
0
Yerushalayim
Query!
Country [18]
0
0
Israel
Query!
State/province [18]
0
0
Haifa
Query!
Country [19]
0
0
Japan
Query!
State/province [19]
0
0
Aichi
Query!
Country [20]
0
0
Japan
Query!
State/province [20]
0
0
Chiba
Query!
Country [21]
0
0
Japan
Query!
State/province [21]
0
0
Fukushima
Query!
Country [22]
0
0
Japan
Query!
State/province [22]
0
0
Gifu
Query!
Country [23]
0
0
Japan
Query!
State/province [23]
0
0
Hiroshima
Query!
Country [24]
0
0
Japan
Query!
State/province [24]
0
0
Hyogo
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Kagoshima
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Osaka
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Saga
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Saitama
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Shizuoka
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Tokyo
Query!
Country [31]
0
0
Korea, Republic of
Query!
State/province [31]
0
0
Seoul Teugbyeolsi
Query!
Country [32]
0
0
New Zealand
Query!
State/province [32]
0
0
Waikato
Query!
Country [33]
0
0
Puerto Rico
Query!
State/province [33]
0
0
Bayamon
Query!
Country [34]
0
0
South Africa
Query!
State/province [34]
0
0
Gauteng
Query!
Country [35]
0
0
Switzerland
Query!
State/province [35]
0
0
Bern
Query!
Country [36]
0
0
Taiwan
Query!
State/province [36]
0
0
Taipei
Query!
Country [37]
0
0
Taiwan
Query!
State/province [37]
0
0
Hsinchu City
Query!
Country [38]
0
0
Taiwan
Query!
State/province [38]
0
0
Taichung
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06257875
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
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/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
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