Ulcerative ColitisPhase 2NCT02768974
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
A Phase 2 study testing OPRX-106 in people with Ulcerative Colitis, run by Protalix at 7 sites in Israel.
Trial summary
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- OPRX-106
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesIsrael
- Study dates
- Sep 2016to Feb 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Have had a diagnosis of ulcerative colitis for a minimum of 3 months
- Have active mild to moderate ulcerative colitis, as defined by a full Mayo score at screening
- Have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results
- High level of calprotectin (>100 mg/kg of stool)
Main Exclusion Criteria:
- Have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy
- .Positive for active/ latent mycobacterium tuberculosis (TB) infection
- .Have a history of infection requiring administration of any IV antibiotic, antiviral or antifungal medication or any oral anti-infective agent
- Severe ulcerative colitis
- Ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge
- Use >4.8 g 5-ASA or equivalent
- Use of corticosteroid or 5-ASA enemas, foams, or suppositories
- Use of anti-inflammatory medications or natural remedies
- Use oral or parenteral antibiotics
- Use of chronic non-steroidal anti-inflammatory (NSAID) therapy
- Use of immune suppressive agents including anti-TNF agents, Azathioprine, 6MP, Methotrexate
- Use of steroids
- Have a diagnosis of: Crohn's disease; Indeterminate colitis; Microscopic colitis; Ischemic or infectious colitis; Clostridium difficile colitis, Parasitic disease
Trial locations and contacts
7 sites in 1 country.
Einat Dekel, DVM contact
7 sites in 1 country
Israel7 sites, 7 recruiting
- Recruiting
Soroka University Hospital
Beersheba
Alexander Fich, MD, Prof.
- Recruiting
Rambam Health Care Campus
Haifa
Mattitiahu Waterman, MD
- Not yet recruiting
Hadassah Medical Center
Jerusalem
Eran Israeli, MD
- Not yet recruiting
Shaare-Zedek Medical Center
Jerusalem
Eran Goldin, MD, Prof.
- Not yet recruiting
Galilee Medical Center
Nahariya
Wisam Sbeit, MD
- Not yet recruiting
Assaf-Harofeh Medical Center
Rishon LeZiyyon
Haim Shirin, MD, Prof.
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
Sigal Fishman, MD
About this study
Official title: An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- OPRX-106
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPRX-106Drug
Oral delivery, once daily.
| Study group | Role | What they receive |
|---|---|---|
| OPRX-106 2 mg | Experimental | Open label, 1:1 randomization ration (up to 10 subjects) Receives: Drug: OPRX-106 |
| OPRX-106 8 mg | Experimental | Open label, 1:1 randomization ration (up to 10 subjects) Receives: Drug: OPRX-106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events following daily administration of OPRX 106
Adverse events from subject reporting or other assessments
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Protalix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Einat Dekel, DVM, Study director, Sr. Director Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768974
- Sponsor's protocol ID
- PB-106-003
- Status last verified
- May 2016
- First submitted
- 27 Mar 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02768974
- Acronym / sponsor ID
- PB-106-003
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ProtalixIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 11 May 2016 (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 is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis. Eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPRX-106 2 mg | Experimental | Drug: OPRX-106Open label, 1:1 randomization ration (up to 10 subjects) |
| OPRX-106 8 mg | Experimental | Drug: OPRX-106Open label, 1:1 randomization ration (up to 10 subjects) |
Who may qualify
- Ages
- 18 to 70 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 |
|---|---|---|
| OPRX-106Oral delivery, once daily. | Drug | OPRX-106 2 mg, OPRX-106 8 mg |
Primary outcome
Adverse events following daily administration of OPRX 106
Time frame: 70 days
Adverse events from subject reporting or other assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Einat Dekel, DVM contact
Einat Dekel, DVM study director
Sr. Director Clinical Development
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPRX-106 in people with Ulcerative Colitis, run by Protalix at 7 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?
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 28 Sep 2016. 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Dekel, DVM (Einat.Dekel@protalix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events following daily administration of OPRX 106 (time frame: 70 days). 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 28 Sep 2016; AzTrials last refreshed its copy on 30 Oct 2026.