Ulcerative ColitisPhase 2NCT01482884
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
A Phase 2 study testing tralokinumab in people with Ulcerative Colitis, run by AstraZeneca at 28 sites in 6 countries.
Trial summary
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- tralokinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 28 sitesin 6 countries
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed ulcerative colitis at least 90 days prior randomisation.
- Men or women age 18 - 75 years.
- Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
- Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
Who cannot join
- Pregnant or breastfeeding women.
- History of colostomy.
- Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
- Hepatitis B, C or HIV.
- History of cancer.
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
France7 sites
Research Site
Amiens
Research Site
Caen
Research Site
Clichy
Research Site
Nice
Research Site
Pessac
Research Site
Rouen
Research Site
Vandœuvre-lès-Nancy
Poland5 sites
Research Site
Bydgoszcz
Research Site
Częstochowa
Research Site
Lodz
Research Site
Sopot
Research Site
Warsaw
Czechia4 sites
Research Site
České Budějovice
Research Site
Hradec Králové
Research Site
Olomouc
Research Site
Prague
Germany4 sites
Research Site
Ludwigshafen
Research Site
Oelde
Research Site
Potsdam
Research Site
Wangen
Italy4 sites
Research Site
Florence
Research Site
Padova
Research Site
Roma
Research Site
Rozzano
United Kingdom4 sites
Research Site
Cambridge
Research Site
Coventry
Research Site
Oxford
Research Site
Shrewsbury
About this study
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
Read the detailed description
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
- Conditions
- Ulcerative Colitis
- Being tested
- tralokinumab, placebo
- Keywords
- tralokinumab, inflammatory bowel disease, moderate to severe ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tralokinumabDrug
2 sc injections of every 2 weeks for 12 weeks.
placeboDrug
2 sc injections of every 2 weeks for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tralokinumab (CAT-354) sc injection Receives: Drug: tralokinumab |
| 2 | Placebo comparator | placebo sc injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Week 8 Based on Mayo Score
Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
Measured: Eight week treatment period
Secondary outcomes (10)
Change in Mayo Score From Baseline to Week 8
Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.
Measured: Eight week treatment period
Mucosal Healing at Week 8 Based on Mayo Score
Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.
Measured: Eight week treatment period
Clinical Remission at Week 8 Based on Mayo Score
Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
Measured: Eight week treatment period
Change From Baseline in Partial Mayo Score
The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.
Measured: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Modified Riley Score
Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.
Measured: Eight week treatment period
Change From Baseline in C - Reactive Protein
Measured: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Albumin
Measured: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Calprotectin
Measured: From baseline to Week 4, 8, 12, 16, 20, and 24.
Serum Concentration of Tralokinumab
Measured: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
Immunogenicity
Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.
Measured: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd
- Responsible party
- Sponsor
- Investigators
- Mark Berner Hansen, MD, PhD, Study director, AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, SwedenSilvio Danese, MD, PhD, Principal investigator, IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482884
- Sponsor's protocol ID
- D2211C00001
- Other IDs
- EudraCT number 2011-004812-40
- Status last verified
- Mar 2016
- First submitted
- 29 Nov 2011
- Last updated
- 5 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.
PubMed 25304132
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01482884
- Acronym / sponsor ID
- D2211C00001
- Conditions
- Ulcerative Colitis
- Keywords
- tralokinumab, inflammatory bowel disease, moderate to severe ulcerative colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune Ltd
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Posted 5 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.
Detailed description
A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tralokinumabtralokinumab (CAT-354) sc injection |
| 2 | Placebo comparator | Drug: placeboplacebo sc injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed ulcerative colitis at least 90 days prior randomisation.
- Men or women age 18 - 75 years.
- Non-hospitalized patients with moderate-severe ulcerative colitis treated with stable background UC therapy (e.g. containing 5-aminosalicylates, and/or low dose of glucocorticosteroids, and/or purine analogue) prior to randomization.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception from Day1.
- Nonsterilized males or sterilized males who are ≤1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception.
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women.
- History of colostomy.
- Current diagnosis of indeterminate colitis, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon and patients with ulcerative colitis limited to the rectum (ulcerative proctitis).
- Hepatitis B, C or HIV.
- History of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tralokinumab2 sc injections of every 2 weeks for 12 weeks. | Drug | 1 |
| placebo2 sc injections of every 2 weeks for 12 weeks. | Drug | 2 |
Primary outcome
Clinical Response at Week 8 Based on Mayo Score
Time frame: Eight week treatment period
Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.
10 secondary outcomes
Change in Mayo Score From Baseline to Week 8
Time frame: Eight week treatment period
Mucosal Healing at Week 8 Based on Mayo Score
Time frame: Eight week treatment period
Clinical Remission at Week 8 Based on Mayo Score
Time frame: Eight week treatment period
Change From Baseline in Partial Mayo Score
Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Modified Riley Score
Time frame: Eight week treatment period
Change From Baseline in C - Reactive Protein
Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Albumin
Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
Change From Baseline in Calprotectin
Time frame: From baseline to Week 4, 8, 12, 16, 20, and 24.
Serum Concentration of Tralokinumab
Time frame: Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.
Immunogenicity
Time frame: Pre-dose sampling at baseline, Week 8, 12, 16, and 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25304132Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.
- D2211C00001\_Protocol\_RedactedLink provided by the sponsor.
- D2211C00001\_Study\_SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Berner Hansen, MD, PhD study director
AstraZeneca R&D Mölndal Pepparedsleden 1, S-431 83 Mölndal, Sweden
Silvio Danese, MD, PhD principal investigator
IBD Center, Instituto Clinico Humanitas, Department of Gastroenterology, Via Manzoni 56, 20089 Rozzano, Milan, Italy
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tralokinumab in people with Ulcerative Colitis, run by AstraZeneca at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in France, Poland, Czechia, Germany, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response at Week 8 Based on Mayo Score (time frame: Eight week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01482884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.