Fistulizing Crohn's DiseasePhase 2NCT01624376
Randomized, Double-blind, Placebo-controlled Study in Patients With Fistulizing Crohn's Disease
A Phase 2 study testing DLX105 in people with Fistulizing Crohn's Disease, run by Delenex Therapeutics AG at 1 site in Switzerland.
Trial summary
The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients. The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fistulizing Crohn's Disease
- What is being tested?
- DLX105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Aug 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Crohn' Disease
- Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration.
- TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders
Who cannot join
- CDAI greater than 450
- ongoing treatment with TNF-blockers (duration of wash-out prior to randomization is 8 weeks)
- Active abscess formation within fistula
- Abdominal or anorectal surgery within the last 4 weeks prior to randomization
- Known immunosuppression
- Infections, sepsis
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- Positive Test for hepatitis B or C and HIV
- Patients who had life vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
- Active liver disease with ALT and/or AST greater than 3x upper limit of normal
- Any severe, progressive or uncontrolled medical condition that in judgment of investigator prevents the patient from participating in the study.
- History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive B-hCG laboratory test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105.
The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.
The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.
Read the detailed description
Beside investigation of the safety and tolerability of locally administered DLX105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of DLX105 (secondary objective).
- Conditions
- Fistulizing Crohn's Disease
- Being tested
- DLX105, Placebo
- Keywords
- non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive
- Medical subject headings
- Fistula, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DLX105Drug
10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
PlaceboDrug
Placebo injections are administered over the treatment period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DLX105 | Active comparator | DLX105 local injection into the identified fistula(s) Receives: Drug: DLX105 |
| Placebo Injection | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Tolerability
Investigator and Patient will assess the local tolerability of DLX105 for each treated fistula using a 10-cm visual analogue scale (VAS) at each study visit. Changes from Baseline will be reported descriptively.
Measured: each study visit after randomization over a period of 4 weeks
Reduction of Number of draining fistulas
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
Measured: Day 29 and Day 43 after randomization
Secondary outcomes (3)
Complete Response
Complete absence of drainage from all of the fistulas treated in a given patient despite gentle finger compression
Measured: Day 29 and Day 43 after randomization
Perianal Disease Activity Index (PDAI) Score
Evaluate the efficacy with completion of PDAI at the given visits.
Measured: Baseline, Day 15, Day 29, Day 43 after randomization
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility
Measured: each study visit over a period of 6 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistulizing 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delenex Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624376
- Sponsor's protocol ID
- DLX105-004-001-001
- Status last verified
- Feb 2014
- First submitted
- 14 Jun 2012
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105.
- ClinicalTrials.gov ID
- NCT01624376
- Acronym / sponsor ID
- DLX105-004-001-001
- Conditions
- Fistulizing Crohn's Disease
- Keywords
- non-invasive management, Fistula, Crohn's Disease, local administration, non-invasive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Delenex Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jun 2012 (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.
The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.
The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.
Detailed description
Beside investigation of the safety and tolerability of locally administered DLX105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of DLX105 (secondary objective).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DLX105 | Active comparator | Drug: DLX105DLX105 local injection into the identified fistula(s) |
| Placebo Injection | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Crohn' Disease
- Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration.
- TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders
Key exclusion criteria (12 listed)
- CDAI greater than 450
- ongoing treatment with TNF-blockers (duration of wash-out prior to randomization is 8 weeks)
- Active abscess formation within fistula
- Abdominal or anorectal surgery within the last 4 weeks prior to randomization
- Known immunosuppression
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 |
|---|---|---|
| DLX10510mg DLX105/injection injected into the fistula over a treatment period of 4 weeks. | Drug | DLX105 |
| PlaceboPlacebo injections are administered over the treatment period of 4 weeks. | Drug | Placebo Injection |
Primary outcome
Local Tolerability
Time frame: each study visit after randomization over a period of 4 weeks
Investigator and Patient will assess the local tolerability of DLX105 for each treated fistula using a 10-cm visual analogue scale (VAS) at each study visit. Changes from Baseline will be reported descriptively.
Reduction of Number of draining fistulas
Time frame: Day 29 and Day 43 after randomization
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
3 secondary outcomes
Complete Response
Time frame: Day 29 and Day 43 after randomization
Perianal Disease Activity Index (PDAI) Score
Time frame: Baseline, Day 15, Day 29, Day 43 after randomization
Number of Participants with Adverse Events as a Measure of Safety and Tolerapility
Time frame: each study visit over a period of 6 weeks after randomization
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 4 Feb 2014.
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MIRICURE: Mirikizumab With Curettage and Repair (Closure) for Perianal Fistulizing Crohn's Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DLX105 in people with Fistulizing Crohn's Disease, run by Delenex Therapeutics AG at 1 site in Switzerland.
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 3 inclusion and 12 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 4 Feb 2014. 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 Switzerland. 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?
Local Tolerability (time frame: each study visit after randomization over a period of 4 weeks). The study lists 2 primary outcomes in all. 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 4 Feb 2014.