InflammationPhase 2NCT01706159
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
A Phase 2 study testing catridecacog in people with Inflammation and Ulcerative Colitis, run by Novo Nordisk A/S at 7 sites in 7 countries.
Trial summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Inflammation, Ulcerative Colitis
- What is being tested?
- catridecacog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Oct 2012to Jul 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
- Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
Who cannot join
- Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
- Requiring hospitalisation for current episode of severe UC
- Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
- Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
- Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
- Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
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- Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
- Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
- Currently receiving total parenteral nutrition
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).
- Conditions
- Inflammation, Ulcerative Colitis
- Being tested
- catridecacog, placebo
- Medical subject headings
- Inflammation, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catridecacogDrug
Also called recombinant factor XIII
Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg
placeboDrug
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
| Study group | Role | What they receive |
|---|---|---|
| rFXIII | Experimental | Not described Receives: Drug: catridecacog |
| Placebo | Active comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Remission Defined as a Modified Baron Score of 0
The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".
Measured: At week 8
Secondary outcomes (4)
Remission (Clinical and Endoscopic)
Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).
Measured: At Week 8
Number of Adverse Events (AEs)
Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.
Measured: Week 0 to 10
Clearance (CL) of rFXIII
The volume of plasma cleared of the drug per unit time.
Measured: Samples were collected before and up to 72 hours after the first dose of rFXIII.
Maximum Concentration (Cmax) of rFXIII
The peak plasma concentration of the drug after dose administration.
Measured: Samples were collected before and up to 72 hours after the first dose of rFXIII.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Trial screening data did not support the medical hypothesis
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.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706159
- Sponsor's protocol ID
- NN8717-3946
- Other IDs
- 2011-001568-22, U1111-1120-3824
- Status last verified
- Sep 2014
- First submitted
- 9 Oct 2012
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01706159
- Acronym / sponsor ID
- NN8717-3946
- Conditions
- Inflammation, Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial screening data did not support the medical hypothesis
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 5 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rFXIII | Experimental | Drug: catridecacog |
| Placebo | Active comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
- Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
Key exclusion criteria (9 listed)
- Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
- Requiring hospitalisation for current episode of severe UC
- Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
- Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
- Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
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 |
|---|---|---|
| catridecacogAlso: recombinant factor XIIICatridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg | Drug | rFXIII |
| placeboPlacebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. | Drug | Placebo |
Primary outcome
Endoscopic Remission Defined as a Modified Baron Score of 0
Time frame: At week 8
The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".
4 secondary outcomes
Remission (Clinical and Endoscopic)
Time frame: At Week 8
Number of Adverse Events (AEs)
Time frame: Week 0 to 10
Clearance (CL) of rFXIII
Time frame: Samples were collected before and up to 72 hours after the first dose of rFXIII.
Maximum Concentration (Cmax) of rFXIII
Time frame: Samples were collected before and up to 72 hours after the first dose of rFXIII.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at Novo NordiskLink 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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing catridecacog in people with Inflammation and Ulcerative Colitis, run by Novo Nordisk A/S at 7 sites in 7 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Bulgaria, Croatia, Denmark, Hungary, Poland and 2 more countries. 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. 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 Aug 2014). 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?
Endoscopic Remission Defined as a Modified Baron Score of 0 (time frame: At week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2014.