Crohn´s DiseasePhase 2TRUST-2NCT01279577
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease
A Phase 2 study testing Low dose TSO, Medium dose TSO and High dose TSO in people with Crohn´s Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only. This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn´s Disease
- What is being tested?
- Low dose TSO, Medium dose TSO and High dose TSO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Major Inclusion Criteria:
- Signed informed consent,
- Man or woman between 18 and 75 years of age,
- Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria,
- Negative pregnancy test in females of childbearing potential.
Major Exclusion Criteria:
- Bowel surgery within the last 3 months prior to baseline,
- Resection of more than 50 cm of the ileum,
- Ileostomy or colostomy,
- Septic complications,
- Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),
- Abscess, perforation, fistulas, or perianal lesions,
- Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
- Clinical signs of stricturing disease,
- Parenteral or tube feeding,
- Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN] at screening), liver cirrhosis, or portal hypertension,
- Abnormal renal function (Cystatin C > ULN) at screening,
- Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results,
- Any condition associated with significant immunosuppression,
- Active malignancy or treatment with anticancer drugs during the last 5 years.
- Existing or intended pregnancy or breast-feeding,
- Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt a.M., Hesse, 60590
About this study
Official title: Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.
This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
- Conditions
- Crohn´s Disease
- Being tested
- Low dose TSO, Medium dose TSO, High dose TSO, Placebo
- Keywords
- Crohn´s disease, Trichuris suis, randomized, placebo, induction of remission, porcine whipworm
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose TSODrug
Low dose TSO suspension
Medium dose TSODrug
Medium dose TSO suspension
High dose TSODrug
High dose TSO suspension
PlaceboDrug
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Low dose TSO | Experimental | Low dose suspension of TSO Receives: Drug: Low dose TSO |
| Medium dose TSO | Experimental | Medium dose suspension of TSO Receives: Drug: Medium dose TSO |
| High dose TSO | Experimental | High dose suspension of TSO Receives: Drug: High dose TSO |
| Placebo | Placebo comparator | Placebo solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
Measured: 12 weeks
Secondary outcomes (2)
Reduction of > 100 points in CDAI
Measured: 12 weeks
Adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn´s DiseaseStudies of the same condition, open and under way.
- 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jürgen Schölmerich, Prof., Principal investigator, Klinikum der Johann Wolfgang Goethe-Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279577
- Sponsor's protocol ID
- TSU-2/CDA
- Other IDs
- 2006-000720-13
- Acronym
- TRUST-2
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2011
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Three Different Dosages of Oral Trichuris Suis Ova (TSO) Suspension in Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT01279577
- Acronym / sponsor ID
- TRUST-2 / TSU-2/CDA
- Conditions
- Crohn´s Disease
- Keywords
- Crohn´s disease, Trichuris suis, randomized, placebo, induction of remission, porcine whipworm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.
This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose TSO | Experimental | Drug: Low dose TSOLow dose suspension of TSO |
| Medium dose TSO | Experimental | Drug: Medium dose TSOMedium dose suspension of TSO |
| High dose TSO | Experimental | Drug: High dose TSOHigh dose suspension of TSO |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Low dose TSOLow dose TSO suspension | Drug | Low dose TSO |
| Medium dose TSOMedium dose TSO suspension | Drug | Medium dose TSO |
| High dose TSOHigh dose TSO suspension | Drug | High dose TSO |
| PlaceboPlacebo solution | Drug | Placebo |
Primary outcome
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150
Time frame: 12 weeks
2 secondary outcomes
Reduction of > 100 points in CDAI
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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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.
Jürgen Schölmerich, Prof. principal investigator
Klinikum der Johann Wolfgang Goethe-Universität
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose TSO, Medium dose TSO and High dose TSO in people with Crohn´s Disease, run by Dr. Falk Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of clinical remission at week 12 (LOCF) defined as a CDAI< 150 (time frame: 12 weeks). 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 10 Feb 2015.