Crohn's DiseasePhase 1/2NCT01094613
Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease
A Phase 1/2 study testing Delayed Release 6 mercaptopurine and 6 Mercaptopurine in people with Crohn's Disease, run by Teva GTC at 11 sites in Israel.
Trial summary
The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and… 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?
- Delayed Release 6 mercaptopurine and 6 Mercaptopurine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 11 sitesIsrael
- Study dates
- Nov 2010to Dec 2012
- Phase
- Phase 1/2
- 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
Who may be able to join
- Male or (non-pregnant) female, 18-75 years (incl) at screen.
- Diagnosed w/CD, appropriately documented/supported by endoscopy or radiology.
- W/ moderately active CD, w/ screen CDAI score 220-450 (inclusive)
- Screen lab tests:
- HGB >/= 8.5 g/dL,
- Platelets >/= 100,000/ mm³
Show all 11Show fewer
- WBC >/= 3500 mm³
- Serum albumin > 2.5 g/dL
- ALT, AST, ALK Phos, GGTP,. total and direct bilirubin < 2xULN
- Subjects may be on stable (for at least 2 wks prior screen) 5-ASA, chronic antibiotics or low-dose oral steroids (prednisolone-up to 15 mg daily; budesonide-up to 6 mg daily) and remain on the drug at that dose throughout the study
- Willing and able to provide written ICF.
Who cannot join
- W/ ulcerative colitis or w/ diagnosis of indeterminate colitis.
- W/ previous bowel resection due to CD resulting in clinically significant Short Bowel Syndrome.
- W/ fistulizing CD w/ clinic or radiologic evidence of abscess.
- W/ clinically significant GI obstructive symptoms or x-ray evidence of fibrosed bowel.
- W/ screen stool culture + for enteric pathogens (Salmonella, Shigella, Campylobacter) or Clostridium difficile toxin assay.
- W/ hx of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed,abdominal abscess,infection or toxic megacolon.
Show all 43Show fewer
- W/ hx of GI tract malignancy or IBD-associated malignant intestinal changes.
- W/ surgery/major procedure in 4 weeks prior to 1st study dose.
- Receiving elemental diet or parenteral nutrition.
- W/ current signs/symptoms of clinically significant/unstable med/surg condition that precludes safe/complete study participation, determined by med history, PE, ECG, lab tests or imaging. Such conditions may include severe, progressive or uncontrolled renal, metabolic, hepatic, hematologic, endocrine, pulmonary, cardiovascular, psychiatric, neurologic, cerebral or autoimmune disease.
- W/ serious infections, such as hepatitis, pneumonia, pyelonephritis w/in 12 weeks prior to 1st study dose. Less serious infections such as acute UR tract infections or uncomplicated UT infection not considered exclusions - at discretion of PI.
- W/ currently known malignancy/pre-malignant lesions/hx of malignancy w/in past 5 years, excl basal cell carcinoma.
- W/ hx of coagulopathy.
- W/ porphyria as it may interfere w/ assessment of CD abdominal pain.
- W/ hx of previous thiopurine failure resulting in serious AE (ex: severe pancreatitis, leucopenia, hepatoxicity or bone marrow suppression) so as to preclude addtl tx w/ 6MP at any dose
- Taking w/in 6 months prior to 1st study dose (+during study) Active vaccinations (live attenuated bacterial/viral pathogens)
- Taking w/in 6 weeks prior to 1st study dose (+ during study):
- Anti-TNFα (infliximab, etanercept, adalimumab)
- Anti-integrin (natalizumab)
- Anti-neoplastics, incl methotrexate, daunorubicin hydrochloride
- Taking w/in 4 weeks prior to 1st study dose (+ during study):
- Immunosuppressants such as AZA, 6-MP (i.e., other than 6MP drug assigned during study), cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide.
- Antibiotics or oral/IV corticosteroids (other than oral prednisolone allowed during study as rescue therapy as per protocol).
- Tx w/ drugs known to induce/inhibit endogenous hepatic drug metabolism such as barbiturates, phenothiazines, cimetidine, carbamazepine etc.
- Anti-coagulant therapy such as: heparin, warfarin, acenocoumarol.
- Medications that induce blood dyscrasias or w/ potential for immune dysfunction, bone marrow depression and/or symptoms of CD (diarrhea, abdominal pain).
- Vaccinations involving inactivated forms of pathogens or purified antigenic proteins (Note: passive immunization involving antibody inoculations permitted at any time)
- Tx w/in 2 wks prior to 1st study dose (+ during study) IV or oral steroids (prednisolone or budesonide) Antibiotics
- Note: 2 impt exceptions (a) Subjects oral steroid or antibiotic dependent with active CD (CDAI 220-450)in spite of these txs, may remain on tx provided on stable (>=2wks at screen)dose and remain at that dose throughout study (b) Subjects who require steroid-rescue during study
- Taking w/in 7 days prior to 1st study dose (+ during study):
- Anticholinergic or other drugs known to affect GI motility.
- Allopurinol
- Proton pump inhibitors or other drugs affecting gastric acidity
- W/body weight below 42.5 kg.
- Pregnant/nursing at screen, or intend to be during study.
- Women of childbearing potential not practicing acceptable method of birth control [acceptable methods: surgical sterilization, IUD, contraceptive (oral, patch, or long-acting injectable), partner's vasectomy, double-protection method (condom or diaphragm w/ spermicide) or abstinence].
- W/ current/hx of drug and/or alcohol abuse.
- Largely or wholly bed-ridden and w/ little capacity for self-care.
- W/ known allergy or hypersensitivity to 6-MP or any inactive component of study drug (ex: lactose intolerant).
- Participated in other clinical trial using investigational drugs w/in 12 weeks prior to 1st study dose.
- W/ planned elective surgery or hospitalization during study (that may interfere w/ study compliance/outcome).
- W/inability to communicate well w/investigators/staff (i.e., language problem, poor mental development or impaired cerebral function).
- Unavailable for trial duration, unable to comply w/schedule, likely to be noncompliant, or felt unsuitable by PI for any other reason.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Israel11 sites
Ha'emek Medical Center
Afula
Bnai Zion Hospital
Haifa
Rambam Medical Center
Haifa
Hadassah Medical Center
Jerusalem
Shaarei Tzedek Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Holy Family Hospital
Nazareth
Kaplan Medical Center
Rehovot
Tel Aviv Sourasky Medical Center
Tel Aviv
Sheba Medical Center
Tel HaShomer
Assaf Harofeh
Tsrifin
About this study
Official title: MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease
The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and mucosal signs and symptoms of moderately active Crohn's Disease
Read the detailed description
Crohn's Disease (CD) therapy is aimed at reducing inflammation via induction of remission after a flare-up and maintenance of the remission for as long as possible. Therapies commonly used for inducing remission are steroids and anti-TNF-a. Standard 6MP, on the other hand, has a slow onset of action and requires several months of administration before its therapeutic effects become apparent. Therefore, 6MP is typically used as maintenance therapy, rather than for remission. Furthermore, serious AE's associated wtih 6MP include leucopenia, hepatoxicity, pancreatitis and bone marrow suppression, requiring lowering of dose or treatment discontinuation.
The Teva DR-6MP project was designed to evaluate a new oral 6MP formulation that would address these limitations. The slow action of standard 6MP, precluding its use as a treatment for induction of remission, would be offset by a faster-disintegrating, more soluble formulation with an enteric coating for targeted ileal delivery. This new formulation designed to open at the terminal ileum, the most commonly affected area of CD bowel involvement, could deliver higher effective local concentrations of drug to the site most affected by CD, stimulating an effective local immunological response, resulting in a cascade of widespread immunological activity, evoking an induction of remission. The safety of standard 6MP would be improved upon by the fact that negligible levels of the DR-6MP formulation have been observed in the plasma, obviating the toxicities associated with systemic 6MP. Moreover, since the DR-6MP dose is fixed and not subject to patient weight, nor potentially, side-effects, the dose adjustments required for up-titration to optimal dose, or down-titration due to toxicity, could be avoided.
Previous small, pilot proof-of-concept clinical efficacy and pharmacokinetic studies of the DR-6MP formulation demonstrated the potential for induction of remission, mucosal healing, systemic immunological improvement and lower systemic side-effects.
The current study is designed to repeat the earlier studies under larger, more rigorous conditions in a randomized, double-blind fashion at multiple sites to ascertain if the initial encouraging results could be repeated. Moreover, a higher dose of 6MP (80 mg) will be tested to ascertain if presumably higher local concentrations at the disease site can evince a more robust clinical effect.
- Conditions
- Crohn's Disease
- Being tested
- Delayed Release 6 mercaptopurine, 6 Mercaptopurine
- Keywords
- Crohn's Disease, Delayed Release, Targeted Ileal Delivery
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Release 6 mercaptopurineDrug
Also called Delayed Release 6 MP tablet (80 mg)
Delayed Release oral tablet for ileal drug delivery, 80 mg, once nightly before bedtime, for 12 weeks.
Since the study drug must be blinded, patients randomized to this arm will receive the following: 80 mg DR-6MP: 2 active 40 mg DR-6MP tablets.
6 MercaptopurineDrug
Also called Purinethol
Oral tablet(s) to be administered once daily in the AM, for 12 weeks.Purinethol is available only as a 50 mg tablet; patients randomized to this arm will receive varying doses (dependent on baseline body weight and AE profile) throughout the study;and study drug to be blinded. Therefore, patients randomized to this arm to receive combination active Purinethol/comparable placebo. For ex: 50 mg Purinethol= 1 active 50 mg tablet, 2 comparable placebo tablets; 100 mg Purinethol = 2 active 50 mg tablets, 1 placebo tablet; 150 mg Purinethol = 3 active 50 mg tablets. Patients receiving 75 mg or 125 mg will receive alternating daily doses of 50 and 100 mg, or 100 and 150 mg, respectively, to arrive at a weekly average dose of 75 mg or 125 mg.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Release 6MP | Experimental | 6 Mercaptopurine delayed release oral tablet for targeted ileal delivery, to be administered once nightly before bedtime, for 12 weeks.
The dose is 2 x 40 mg DR-6MP (total dose, 80 mg DR-6MP). Receives: Drug: Delayed Release 6 mercaptopurine |
| Purinethol | Active comparator | 6 Mercaptopurine Tablet (50 mg) administered orally, at doses of 1-1.5 mg/kg body weight, daily for 12 weeks. Individual patient doses range from 50 mg to 150 mg, including 75, 100 and 125 mg daily, as per patient weight at baseline, and then are up-titrated to clinical efficacy at two week intervals, as needed. Doses may be down-titrated as well if occurrences of AE's warrant dose reduction. Receives: Drug: 6 Mercaptopurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with clinical response at study end
Clinical response is defined as a reduction in CDAI score (Crohn's Disease Activity Index) by 100 points from baseline, or remission (CDAI score <150),even if it is achieved with reduction of CDAI score of less than 100 points from baseline
Measured: 12 weeks
Secondary outcomes (1)
Time to clinical response
Although the primary outcome is to assess the proportion of patients with clinical response at Week 12, we are also interested to see how early during treatment (i.e., between weeks 2 and 12), was this clinical response actually achieved for each treatment group, and if it was maintained until the end of the study (week 12)
Measured: Week 2, 4, 6, 8 or 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Sponsor withdrew support of study due to reorganization and project prioritization
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva GTC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaron Ilan, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094613
- Sponsor's protocol ID
- Protocol C2/13/DR-6MP-02
- Status last verified
- Mar 2013
- First submitted
- 25 Mar 2010
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT01094613
- Acronym / sponsor ID
- Protocol C2/13/DR-6MP-02
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Delayed Release, Targeted Ileal Delivery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew support of study due to reorganization and project prioritization
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Teva GTCIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Mar 2010 (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 study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and mucosal signs and symptoms of moderately active Crohn's Disease
Detailed description
Crohn's Disease (CD) therapy is aimed at reducing inflammation via induction of remission after a flare-up and maintenance of the remission for as long as possible. Therapies commonly used for inducing remission are steroids and anti-TNF-a. Standard 6MP, on the other hand, has a slow onset of action and requires several months of administration before its therapeutic effects become apparent. Therefore, 6MP is typically used as maintenance therapy, rather than for remission. Furthermore, serious AE's associated wtih 6MP include leucopenia, hepatoxicity, pancreatitis and bone marrow suppression, requiring lowering of dose or treatment discontinuation.
The Teva DR-6MP project was designed to evaluate a new oral 6MP formulation that would address these limitations. The slow action of standard 6MP, precluding its use as a treatment for induction of remission, would be offset by a faster-disintegrating, more soluble formulation with an enteric coating for targeted ileal delivery. This new formulation designed to open at the terminal ileum, the most commonly affected area of CD bowel involvement, could deliver higher effective local concentrations of drug to the site most affected by CD, stimulating an effective local immunological response, resulting in a cascade of widespread immunological activity, evoking an induction of remission. The safety of standard 6MP would be improved upon by the fact that negligible levels of the DR-6MP formulation have been observed in the plasma, obviating the toxicities associated with systemic 6MP. Moreover, since the DR-6MP dose is fixed and not subject to patient weight, nor potentially, side-effects, the dose adjustments required for up-titration to optimal dose, or down-titration due to toxicity, could be avoided.
Previous small, pilot proof-of-concept clinical efficacy and pharmacokinetic studies of the DR-6MP formulation demonstrated the potential for induction of remission, mucosal healing, systemic immunological improvement and lower systemic side-effects.
The current study is designed to repeat the earlier studies under larger, more rigorous conditions in a randomized, double-blind fashion at multiple sites to ascertain if the initial encouraging results could be repeated. Moreover, a higher dose of 6MP (80 mg) will be tested to ascertain if presumably higher local concentrations at the disease site can evince a more robust clinical effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Release 6MP | Experimental | Drug: Delayed Release 6 mercaptopurine6 Mercaptopurine delayed release oral tablet for targeted ileal delivery, to be administered once nightly before bedtime, for 12 weeks. The dose is 2 x 40 mg DR-6MP (total dose, 80 mg DR-6MP). |
| Purinethol | Active comparator | Drug: 6 Mercaptopurine6 Mercaptopurine Tablet (50 mg) administered orally, at doses of 1-1.5 mg/kg body weight, daily for 12 weeks. Individual patient doses range from 50 mg to 150 mg, including 75, 100 and 125 mg daily, as per patient weight at baseline, and then are up-titrated to clinical efficacy at two week intervals, as needed. Doses may be down-titrated as well if occurrences of AE's warrant dose reduction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or (non-pregnant) female, 18-75 years (incl) at screen.
- Diagnosed w/CD, appropriately documented/supported by endoscopy or radiology.
- W/ moderately active CD, w/ screen CDAI score 220-450 (inclusive)
- Screen lab tests:
- Subjects may be on stable (for at least 2 wks prior screen) 5-ASA, chronic antibiotics or low-dose oral steroids (prednisolone-up to 15 mg daily; budesonide-up to 6 mg daily) and remain on the drug at that dose throughout the study
Key exclusion criteria (43 listed)
- W/ ulcerative colitis or w/ diagnosis of indeterminate colitis.
- W/ previous bowel resection due to CD resulting in clinically significant Short Bowel Syndrome.
- W/ fistulizing CD w/ clinic or radiologic evidence of abscess.
- W/ clinically significant GI obstructive symptoms or x-ray evidence of fibrosed bowel.
- W/ screen stool culture + for enteric pathogens (Salmonella, Shigella, Campylobacter) or Clostridium difficile toxin assay.
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 |
|---|---|---|
| Delayed Release 6 mercaptopurineAlso: Delayed Release 6 MP tablet (80 mg)Delayed Release oral tablet for ileal drug delivery, 80 mg, once nightly before bedtime, for 12 weeks. Since the study drug must be blinded, patients randomized to this arm will receive the following: 80 mg DR-6MP: 2 active 40 mg DR-6MP tablets. | Drug | Delayed Release 6MP |
| 6 MercaptopurineAlso: PurinetholOral tablet(s) to be administered once daily in the AM, for 12 weeks.Purinethol is available only as a 50 mg tablet; patients randomized to this arm will receive varying doses (dependent on baseline body weight and AE profile) throughout the study;and study drug to be blinded. Therefore, patients randomized to this arm to receive combination active Purinethol/comparable placebo. For ex: 50 mg Purinethol= 1 active 50 mg tablet, 2 comparable placebo tablets; 100 mg Purinethol = 2 active 50 mg tablets, 1 placebo tablet; 150 mg Purinethol = 3 active 50 mg tablets. Patients receiving 75 mg or 125 mg will receive alternating daily doses of 50 and 100 mg, or 100 and 150 mg, respectively, to arrive at a weekly average dose of 75 mg or 125 mg. | Drug | Purinethol |
Primary outcome
Proportion of subjects with clinical response at study end
Time frame: 12 weeks
Clinical response is defined as a reduction in CDAI score (Crohn's Disease Activity Index) by 100 points from baseline, or remission (CDAI score <150),even if it is achieved with reduction of CDAI score of less than 100 points from baseline
1 secondary outcome
Time to clinical response
Time frame: Week 2, 4, 6, 8 or 12
Results and safety
The study was stopped early (reason given: Sponsor withdrew support of study due to reorganization and project prioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2013.
- Previous pilot studies (proof of concept efficacy and pk studies) conducted on the DR6MP tabletLink 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.
Yaron Ilan, MD principal investigator
Hadassah Medical Organization
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Delayed Release 6 mercaptopurine and 6 Mercaptopurine in people with Crohn's Disease, run by Teva GTC at 11 sites in Israel.
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 11 inclusion and 43 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 7 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor withdrew support of study due to reorganization and project prioritization). Results are not available in the source record.
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?
Proportion of subjects with clinical response at study end (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 7 Mar 2013.