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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04985968




Registration number
NCT04985968
Ethics application status
Date submitted
22/07/2021
Date registered
2/08/2021

Titles & IDs
Public title
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Scientific title
A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Secondary ID [1] 0 0
CSUC-01/21
Universal Trial Number (UTN)
Trial acronym
CONCLUDE
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 - Cobitolimod 250 mg
Treatment: Drugs - Cobitolimod 500 mg
Treatment: Drugs - Placebo

Experimental: Cobitolimod 250 mg - Dose of 250 mg cobitolimod

2 treatments during induction study and subsequently every third week

Experimental: Cobitolimod 500 mg - Dose of 500 mg cobitolimod

2 treatments during induction study and subsequently every third week

Placebo comparator: Placebo - Dose of Placebo

2 treatments during induction study and subsequently every third week


Treatment: Drugs: Cobitolimod 250 mg
Rectal administration

Treatment: Drugs: Cobitolimod 500 mg
Rectal administration

Treatment: Drugs: Placebo
Rectal administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction - Proportion of participants with clinical remission.
Timepoint [1] 0 0
Week 6
Primary outcome [2] 0 0
Maintenance - Proportion of participants with clinical remission.
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
Induction - Proportion of participants with endoscopic improvement.
Timepoint [1] 0 0
Week 6
Secondary outcome [2] 0 0
Induction - Proportion of participants with symptomatic remission.
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Induction - Proportion of participants with clinical response.
Timepoint [3] 0 0
Week 6
Secondary outcome [4] 0 0
Induction - Proportion of participants with normalisation of stool frequency.
Timepoint [4] 0 0
Week 6
Secondary outcome [5] 0 0
Induction - Proportion of participants with absence of rectal bleeding.
Timepoint [5] 0 0
Week 6
Secondary outcome [6] 0 0
Induction - Mean stool frequency.
Timepoint [6] 0 0
Week 6
Secondary outcome [7] 0 0
Induction - Proportion of participants with histologic improvement.
Timepoint [7] 0 0
Week 6
Secondary outcome [8] 0 0
Induction - Proportion of participants with histologic remission.
Timepoint [8] 0 0
Week 6
Secondary outcome [9] 0 0
Induction - Proportion of participants with mucosal healing.
Timepoint [9] 0 0
Week 6
Secondary outcome [10] 0 0
Induction - Mean ln-transformed faecal calprotectin.
Timepoint [10] 0 0
Week 6
Secondary outcome [11] 0 0
Induction - Mean 3-component and 4-component Mayo scores.
Timepoint [11] 0 0
Week 6
Secondary outcome [12] 0 0
Induction - Mean IBDQ total score.
Timepoint [12] 0 0
Week 6
Secondary outcome [13] 0 0
Induction - Proportion of participants with an improvement in IBDQ total score.
Timepoint [13] 0 0
Week 6
Secondary outcome [14] 0 0
Maintenance - Proportion of participants with endoscopic improvement.
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Maintenance - Proportion of participants with clinical remission and steroid-free.
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Maintenance - Proportion of participants with symptomatic remission.
Timepoint [17] 0 0
Week 52
Secondary outcome [18] 0 0
Maintenance - Proportion of participants with histologic improvement.
Timepoint [18] 0 0
Week 52
Secondary outcome [19] 0 0
Maintenance - Proportion of participants with histologic remission.
Timepoint [19] 0 0
Week 52
Secondary outcome [20] 0 0
Maintenance - Proportion of participants with mucosal healing.
Timepoint [20] 0 0
Week 52
Secondary outcome [21] 0 0
Maintenance - Proportion of participants with clinical response.
Timepoint [21] 0 0
Week 52
Secondary outcome [22] 0 0
Maintenance - Proportion of participants with absence of rectal bleeding.
Timepoint [22] 0 0
Week 52
Secondary outcome [23] 0 0
Maintenance - Proportion of participants with normalisation of stool frequency.
Timepoint [23] 0 0
Week 52
Secondary outcome [24] 0 0
Maintenance - Mean stool frequency.
Timepoint [24] 0 0
Week 52
Secondary outcome [25] 0 0
Maintenance - Mean ln-transformed faecal calprotectin.
Timepoint [25] 0 0
Week 52
Secondary outcome [26] 0 0
Maintenance - Mean 3-component and 4-component Mayo scores.
Timepoint [26] 0 0
Week 52
Secondary outcome [27] 0 0
Maintenance - Mean IBDQ total score.
Timepoint [27] 0 0
Week 52
Secondary outcome [28] 0 0
Maintenance - Proportion of participants with an improvement in IBDQ total score.
Timepoint [28] 0 0
Week 52

Eligibility
Key inclusion criteria
Inclusion Criteria Induction:

* Male or female = 18 years of age.
* Established diagnosis of UC.
* Moderate to severe active left-sided UC assessed by central reading.
* Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
* Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (=20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
* Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Induction:

* Suspicion of differential diagnosis.
* Acute fulminant UC and/or signs of systemic toxicity.
* UC limited to the rectum or extending beyond the splenic flexure.
* Have failed treatment with more than three advanced therapies of two different therapeutic classes.
* Have had surgery for treatment of UC.
* History of malignancy, unless treated with no relapse of the disease and = 5 years since last treatment (cured).
* History or presence of any clinically significant disorder.
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
* Long-term treatment (>14 days) with antibiotics or NSAIDs .
* Serious known active infection including history of latent or active tuberculosis.
* Gastrointestinal infections including positive Clostridium difficile stool assay.
* Females who are lactating or have a positive serum pregnancy test.
* Women of childbearing potential not using highly effective contraceptive methods.
* Concurrent participation in another clinical study.
* Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

* Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

* Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.

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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2023
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Fitzroy
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- Melbourne
Recruitment postcode(s) [4] 0 0
- Parkville
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- South Brisbane
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
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United States of America
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Bury
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Darlington
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Glasgow
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Reading

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Raja Atreya, Professor
Address 0 0
Friedrich-Alexander University Erlangen-Nuremberg
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT04985968