Mild to Moderate Ulcerative ColitisPhase 1/2NCT01039597
Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis
A Phase 1/2 study testing ORE1001 in people with Mild to Moderate Ulcerative Colitis, run by Ore Pharmaceuticals, Inc. at 7 sites in 2 countries.
Trial summary
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mild to Moderate Ulcerative Colitis
- What is being tested?
- ORE1001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2009to Jun 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as demonstrated clinically and by endoscopy at Visit 2.
- Baron score greater than or equal to 2 at baseline.
- Truelove-Witt (modified) score of 14 or less.
- At least 6 months duration of disease
- At baseline the subject should have either stable disease or stable disease requiring 5-ASA treatment
- If on a 5-ASA treatment, subject must have been on stable dose for at least two weeks prior to screening and is expected to continue on that dose until the study is completed
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- Subject has normally functioning major organ systems (aside from gastrointestinal tract) as indicated by medical history, vital signs, physical exam and clinical laboratories (including hematology, coagulation, chemistries and urinalysis).
- Male or female subjects 18-70 years old
- Subject has provided voluntary written informed consent to participate in this study.
- Subject may be of child-bearing potential, but is not pregnant, nursing, or planning a pregnancy for the duration of the study and has a negative pregnancy test prior to enrollment.
- Subject agrees to use a medically-acceptable form of contraception from screening through 30 days after the final dose of study drug. Female partners of male subjects enrolled into this study are also recommended to use an acceptable method of birth control. Males must agree to not donate sperm during the entire study and for 90 days after the last dose of study drug.
Who cannot join
- A clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize the safety of the subject, impact the validity of the study results, or interfere with the completion of treatment according to this protocol.
- Subject has an ALT or serum creatinine greater than 1.5 times the upper limit of normal range for the reference lab at screening.
- Subject who, in the opinion of the investigator, is febrile at screening.
- Subject had used the following treatments for IBD: steroids or any or biologic immunomodulators or any topical treatments (e.g. enemas) within the last 4 weeks prior to baseline, immunosuppressants or antimetabolites within the preceding 6 weeks, antibiotic use within the previous 7 days or chronic use of any anti-inflammatory drugs (except aminosalicylates) within 7 days.
- History of illicit drug abuse or positive urine screen for drugs of abuse or history of alcohol abuse if acknowledged at the screening visit or noted in the subject's medical record at screening.
- Subject has a positive blood screen for HIV, Hepatitis B (HBsAg), or Hepatitis C.
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- Subject has evidence of infectious colitis, e.g., Clostridium difficile, Amoebiasis, Giardia lamblia by stool examination of at screening.
- Subject has evidence for gastrointestinal parasites as per stool ova and parasites testing at screening.
- Subject has evidence of tuberculosis by blood interferon gamma release assay at screening.
- Any uncontrolled, intercurrent illness (e.g., active infection).
- History of gastrointestinal cancer.
- Abdominal surgery or any major surgery within the preceding 28 days of the screening visit.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
India6 sites, 6 recruiting
- Recruiting
Dr, Bhatnagar's Clinic
Ahmedabad, Gujarat, 380009
Alpesh Thakkar, alpesh@transmedindia.com
Manish Bhatnagar, M.D.
- Recruiting
St. John's Medical College Hospital
Bangalore, Karnatka, 560034
Channa Basava, channa@transmedindia.com
Harashad Devarbhavi, M.D.
- Recruiting
B.Y.L. Nair Hospital
Bombay, Maharashtra, 400008
Alpesh Thakkar, alpesh@transmedindia.com
Pravin Rathi, M.D.
- Recruiting
Gut-n-HEPA Care
Indore, Madhya Pradesh, 452001
Alpesh Thakkar, alpesh@transmedindia.com
Atul Shende, M.D.
- Recruiting
Amol Gastroenterology Hospital
Indore, Madhya Pradesh, 452003
Alpesh Thakkar, alpesh@transmedindia.com
Sulil Jain, M.D.
- Recruiting
Vikram Jyoth Centre for Advanced Gastroenterology
Mysore, Karnataka, 570002
Channa Basava, Channa@transmedindia.com
Rajkumar Wadhwa, M.
Canada1 site, 1 recruiting
- Recruiting
Robarts Research Institute
London, Ontario, N6A5K8
Margeret K Vandervoort, M.S.
William Barnett, M.D.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
Read the detailed description
This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with Ulcerative Colitis.
Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively. Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6.
Subjects will be instructed to self-administer the study drug on an outpatient basis and will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks 10-12.
- Conditions
- Mild to Moderate Ulcerative Colitis
- Being tested
- ORE1001, Placebo
- Keywords
- IBD, Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORE1001Drug
Also called GL1001
Oral capsules containing 300 mg of the active, study drug
PlaceboDrug
Also called matched placebo
placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Active study drug | Experimental | ORE1001 300 mg oral capsules Receives: Drug: ORE1001 |
| Placebo control | Placebo comparator | 300 mg oral capsules containing placebo material Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
Measured: 6 Week
Secondary outcomes (6)
Change in the modified Baron Score from Baseline to Week 6
Measured: 6 Week
Change in the Ulcerative Colitis Clinical Score from Baseline
Measured: 6 Week
Change in the partial Mayo Score fom baseline
Measured: 6 week
Calprotectin concentrations
Measured: 6 week
Riley Acute Inflammation Scale (histology)
Measured: 6 week
Clinical remission
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Ulcerative ColitisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ore Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039597
- Sponsor's protocol ID
- ORX102
- Status last verified
- Jun 2011
- First submitted
- 23 Dec 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Byrnes JJ, Gross S, Ellard C, Connolly K, Donahue S, Picarella D. Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice. Inflamm Res. 2009 Nov;58(11):819-27. doi: 10.1007/s00011-009-0053-3. Epub 2009 Jun 11.
PubMed 19517214
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01039597
- Acronym / sponsor ID
- ORX102
- Conditions
- Mild to Moderate Ulcerative Colitis
- Keywords
- IBD, Ulcerative colitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ore Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Dec 2009 (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.
A clinical trial is being conducted to test the effects of a potential new treatment in patients with ulcerative colitis. Study participants will be given capsules containing either ORE1001 or a matching placebo capsule and will take the medicine by mouth for six weeks. Study participants will be asked to visit clinic sites where they will be asked questions about their ulcerative colitis. Small samples of blood will be be drawn at study visits to monitor the participant's health and a tiny sample of tissue will be taken in an endoscopy at two times to determine whether the disease is getting better or worse.
Detailed description
This is a Phase Ib/IIa prospective, multicenter, double blind, randomized, placebo controlled, clinical study to evaluate the safety, tolerability and pilot therapeutic activity of ORE1001, administered as capsules by mouth, for 6 weeks in subjects with Ulcerative Colitis.
Eligible subjects will be randomly assigned to either ORE1001 or placebo, respectively. Sigmoidoscopies with biopsies will be performed at the first treatment visit and week 6.
Subjects will be instructed to self-administer the study drug on an outpatient basis and will be scheduled to return for clinical evaluation on weeks 2, 4, 6 and between Weeks 10-12.
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 |
|---|---|---|
| Active study drug | Experimental | Drug: ORE1001ORE1001 300 mg oral capsules |
| Placebo control | Placebo comparator | Drug: Placebo300 mg oral capsules containing placebo material |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has a documented diagnosis of mild to moderate Ulcerative Colitis, as demonstrated clinically and by endoscopy at Visit 2.
- Baron score greater than or equal to 2 at baseline.
- Truelove-Witt (modified) score of 14 or less.
- At least 6 months duration of disease
- At baseline the subject should have either stable disease or stable disease requiring 5-ASA treatment
Key exclusion criteria (12 listed)
- A clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize the safety of the subject, impact the validity of the study results, or interfere with the completion of treatment according to this protocol.
- Subject has an ALT or serum creatinine greater than 1.5 times the upper limit of normal range for the reference lab at screening.
- Subject who, in the opinion of the investigator, is febrile at screening.
- Subject had used the following treatments for IBD: steroids or any or biologic immunomodulators or any topical treatments (e.g. enemas) within the last 4 weeks prior to baseline, immunosuppressants or antimetabolites within the preceding 6 weeks, antibiotic use within the previous 7 days or chronic use of any anti-inflammatory drugs (except aminosalicylates) within 7 days.
- History of illicit drug abuse or positive urine screen for drugs of abuse or history of alcohol abuse if acknowledged at the screening visit or noted in the subject's medical record at screening.
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 |
|---|---|---|
| ORE1001Also: GL1001Oral capsules containing 300 mg of the active, study drug | Drug | Active study drug |
| PlaceboAlso: matched placeboplacebo capsules | Drug | Placebo control |
Primary outcome
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events
Time frame: 6 Week
6 secondary outcomes
Change in the modified Baron Score from Baseline to Week 6
Time frame: 6 Week
Change in the Ulcerative Colitis Clinical Score from Baseline
Time frame: 6 Week
Change in the partial Mayo Score fom baseline
Time frame: 6 week
Calprotectin concentrations
Time frame: 6 week
Riley Acute Inflammation Scale (histology)
Time frame: 6 week
Clinical remission
Time frame: Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Background: PubMed 19517214Byrnes JJ, Gross S, Ellard C, Connolly K, Donahue S, Picarella D. Effects of the ACE2 inhibitor GL1001 on acute dextran sodium sulfate-induced colitis in mice. Inflamm Res. 2009 Nov;58(11):819-27. doi: 10.1007/s00011-009-0053-3. Epub 2009 Jun 11.
- Colitis and Crohn's Foundation of AmericaLink 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ORE1001 in people with Mild to Moderate Ulcerative Colitis, run by Ore Pharmaceuticals, Inc. at 7 sites in 2 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 11 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: status not confirmed, as of the sponsor's last update on 8 Jun 2011. 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 India, Canada. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John F Reinhard, Ph.D. ((617) 250-8620, jreinhard@orepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and tolerability of ORE1001 in subjects with ulcerative colitis as demonstrated by the frequency and severity of adverse events (time frame: 6 Week). 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 NCT01039597, 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 8 Jun 2011.