Ulcerative ColitisPhase 3PROTECT-3NCT02849951
A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)
A Phase 3 study testing LT-02 in people with Ulcerative Colitis, run by Prometheus Laboratories at 45 sites in United States.
Trial summary
The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine 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?
- LT-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 45 sitesUnited States
- Study dates
- Jul 2016to Aug 2019
- Phase
- Phase 3
- 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
- Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
- Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
- A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
- Mesalamine (5-ASA) refractory.
Who cannot join
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Prior colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
- Known celiac disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
Show all 11Show fewer
- History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
- Subjects with known hypersensitivity to soy,
- Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening,
- Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
- Treatment with other investigational drug within last 8 weeks prior to screening,
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
Prometheus Site 37
Athens, Georgia, 30607
Prometheus Research Site 1
Brockton, Massachusetts, 02379
Prometheus Site 34
Charlottesville, Virginia, 22911
Prometheus Site 6
Chesterfield, Michigan, 48047
Prometheus Site 5
Chevy Chase, Maryland, 20815
Prometheus Site 53
Chicago, Illinois, 60624
Prometheus Site 15
Chula Vista, California, 91910
Prometheus Site 35
Clearwater, Florida, 33756
Prometheus Site 43
Columbia, South Carolina, 29203
Prometheus Site 11
Decatur, Georgia, 30033
Prometheus Site 17
Fort Lauderdale, Florida, 33319
Prometheus Site 22
Great Neck, New York, 11021
Prometheus Site 41
Greenville, North Carolina, 27834
Prometheus Site 55
Hialeah, Florida, 33016
Prometheus Site 54
Hoffman Estates, Illinois, 60169
Prometheus Site 49
Houston, Texas, 77090
Prometheus Site 39
Humble, Texas, 77338
Prometheus Site 32
Kinston, North Carolina, 28501
Prometheus Site 27
Lafayette, Colorado, 80026
Prometheus Site 42
Lancaster, California, 93534
Prometheus Site 21
Lebanon, New Hampshire, 03756
Prometheus Site 10
Little Rock, Arkansas, 72205
Prometheus Site 45
Lone Tree, Colorado, 80124
Prometheus Site 8
Naples, Florida, 34102
Prometheus Site 13
Naples, Florida, 34110
Prometheus Site 30
Oceanside, California, 92056
Prometheus Site 23
Orem, Utah, 84058
Prometheus Site 36
Orlando, Florida, 32803
Prometheus Site 44
Orlando, Florida, 32807
Prometheus Site 24
Phoenix, Arizona, 85018
Prometheus Site 31
Plymouth, Minnesota, 55446
Prometheus Site 33
Poughkeepsie, New York, 12601
Prometheus Site 7
Rapid City, South Dakota, 57701
Prometheus Site 28
Rialto, California, 92377
Prometheus Site 12
Richland, Washington, 99352
Prometheus Site 25
Salt Lake City, Utah, 84107
Prometheus Site 47
San Antonio, Texas, 78229
Prometheus Site 9
San Antonio, Texas, 78229
Prometheus Site 4
Shreveport, Louisiana, 71105
Prometheus Site 51
Southfield, Michigan, 48034
Prometheus Site 40
St Louis, Missouri, 63128
Prometheus Site 26
The Bronx, New York, 10467
Prometheus Site 20
Topeka, Kansas, 66606
Prometheus Site 2
Ventura, California, 93003
Prometheus Site 48
Wyoming, Michigan, 49519
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine
Read the detailed description
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.
- Conditions
- Ulcerative Colitis
- Being tested
- LT-02, LT-02 Placebo
- Keywords
- Colitis, Colitis, Ulcerative, Ulcer, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases, Intestinal Diseases, Pathologic Processes, Mesalamine
- Medical subject headings
- Colitis, Ulcerative, Colitis, Ulcer, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-02Drug
12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
LT-02 PlaceboDrug
12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo
| Study group | Role | What they receive |
|---|---|---|
| LT-02 | Experimental | 1.6 g PC in LT-02 BID Receives: Drug: LT-02 |
| LT-02 Placebo | Placebo comparator | 0 g PC in LT-02 Placebo BID Receives: Drug: LT-02 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical remission
The percentage of subjects in clinical remission using the abbreviated modified Mayo score
Measured: 12 weeks
Secondary outcomes (6)
Clinical response
Percentage of subjects with clinical response using the abbreviated modified Mayo score
Measured: 12 weeks
Endoscopic response
Percentage of subjects with endoscopic response
Measured: 12 weeks
Histological improvement
Percentage of subjects with histological improvement
Measured: 12 weeks
Endoscopic remission
Percentage of subjects with endoscopic remission
Measured: 12 weeks
Mucosal healing
Percentage of subjects with mucosal healing
Measured: 12 weeks
Quality of life
Change in the subjects quality of life, using Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ)
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 posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019 (estimated)
- Study completionAug 2019 (estimated)
Why it stopped: LT-02 did not appear to help induce remission of UC
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prometheus Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nestlé Health Science Spain, Syneos Health
- Responsible party
- Sponsor
- Investigators
- Gregory Gordon, M.D., J.D., Study director, Nestle Health Science, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849951
- Sponsor's protocol ID
- 16GI01
- Acronym
- PROTECT-3
- Status last verified
- Jun 2017
- First submitted
- 26 Jul 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
- ClinicalTrials.gov ID
- NCT02849951
- Acronym / sponsor ID
- PROTECT-3 / 16GI01
- Conditions
- Ulcerative Colitis
- Keywords
- Colitis, Colitis, Ulcerative, Ulcer, Colonic Diseases, Digestive System Diseases, Gastroenteritis, Gastrointestinal Diseases, Inflammatory Bowel Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LT-02 did not appear to help induce remission of UC
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Prometheus LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Nestlé Health Science Spain, Syneos Health
- Study start
- Jul 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 29 Jul 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.
The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine
Detailed description
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.
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 |
|---|---|---|
| LT-02 | Experimental | Drug: LT-021.6 g PC in LT-02 BID |
| LT-02 Placebo | Placebo comparator | Drug: LT-02 Placebo0 g PC in LT-02 Placebo BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
- Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
- A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
- Mesalamine (5-ASA) refractory.
Key exclusion criteria (11 listed)
- Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Prior colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
- Known celiac disease
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 |
|---|---|---|
| LT-0212-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02) | Drug | LT-02 |
| LT-02 Placebo12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo | Drug | LT-02 Placebo |
Primary outcome
Rate of clinical remission
Time frame: 12 weeks
The percentage of subjects in clinical remission using the abbreviated modified Mayo score
6 secondary outcomes
Clinical response
Time frame: 12 weeks
Endoscopic response
Time frame: 12 weeks
Histological improvement
Time frame: 12 weeks
Endoscopic remission
Time frame: 12 weeks
Mucosal healing
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: LT-02 did not appear to help induce remission of UC). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Gregory Gordon, M.D., J.D. study director
Nestle Health Science, Medical Director
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LT-02 in people with Ulcerative Colitis, run by Prometheus Laboratories at 45 sites in United States.
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 4 inclusion and 11 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 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: LT-02 did not appear to help induce remission of UC). 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?
Rate of clinical remission (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 15 Jun 2017.