Ulcerative ColitisPhase 3PROTECT-2NCT02280629
Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)
A Phase 3 study testing LT-02 and Mesalamine in people with Ulcerative Colitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
Trial summary
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC) 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 and Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2014to 5 Oct 2018
- 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
Major Inclusion Criteria:
- Signed informed consent
- Men or women, 18 to 70 years of age
- Historically confirmed diagnosis of UC by endoscopy and histology
- Patients being in clinical and endoscopical remission at baseline
- Negative pregnancy test in females of childbearing potential at baseline visit
Major Exclusion Criteria:
- 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
- Colon resection
- Malabsorption syndromes
- Celiac disease
- Bleeding hemorrhoids
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding
- History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
- Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
- Any relevant known systemic disease (e.g., AIDS, active tuberculosis)
- Severe co-morbidity substantially reducing life expectancy
- History of cancer in the last five years
- Abnormal hepatic function at screening visit, liver cirrhosis
- Abnormal renal function at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine)
- Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization
- Treatment with methotrexate within last 6 weeks prior to randomization
- Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization
- Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization
- Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02
- Existing or intended pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis
The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
- Conditions
- Ulcerative Colitis
- Being tested
- LT-02, Placebo, Mesalamine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-02Drug
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
PlaceboDrug
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
MesalamineDrug
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
| Study group | Role | What they receive |
|---|---|---|
| LT-02 | Experimental | LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily Receives: Drug: LT-02 |
| Placebo | Placebo comparator | LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily Receives: Drug: Placebo |
| Mesalamine | Active comparator | LT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily Receives: Drug: Mesalamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who are relapse-free and are not a treatment failure
Measured: 48 weeks
Secondary outcomes (1)
Mean change from baseline in the total mDAI
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start1 Oct 2014
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
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 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Dignass, Prof Dr, Principal investigator, Agaplesion Markus Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280629
- Sponsor's protocol ID
- PCG-4/UCR
- Other IDs
- 2013-001205-84
- Acronym
- PROTECT-2
- Status last verified
- Jan 2020
- First submitted
- 29 Oct 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.
PubMed 37806372
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02280629
- Acronym / sponsor ID
- PROTECT-2 / PCG-4/UCR
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 31 Oct 2014 (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 prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LT-02 | Experimental | Drug: LT-02LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily |
| Placebo | Placebo comparator | Drug: PlaceboLT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily |
| Mesalamine | Active comparator | Drug: MesalamineLT-02 PLACEBO twice daily AND 500mg mesalamine PLACEBO three-times daily |
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 |
|---|---|---|
| LT-02LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily | Drug | LT-02 |
| PlaceboLT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily | Drug | Placebo |
| MesalamineLT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily | Drug | Mesalamine |
Primary outcome
Percentage of patients who are relapse-free and are not a treatment failure
Time frame: 48 weeks
1 secondary outcome
Mean change from baseline in the total mDAI
Time frame: 48 weeks
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 27 Jan 2020.
- Derived from this study: PubMed 37806372Dignass A, Stremmel W, Horynski M, Poyda O, Armerding P, Fellermann K, Langhorst J, Kuehbacher T, Uebel P, Stein J, Novacek G, Avalueva E, Oliinyk O, Hasselblatt P, Dorofeyev A, Heinemann H, Mueller R, Greinwald R, Reinisch W; International PROTECT-1/2 Study Groups. Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials. Clin Gastroenterol Hepatol. 2024 Apr;22(4):810-820.e7. doi: 10.1016/j.cgh.2023.09.031. Epub 2023 Oct 6.
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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.
Axel Dignass, Prof Dr principal investigator
Agaplesion Markus Krankenhaus
1 site 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 and Mesalamine in people with Ulcerative Colitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.
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: finished, as of the sponsor's last update on 27 Jan 2020. 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 Germany. 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 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?
Percentage of patients who are relapse-free and are not a treatment failure (time frame: 48 weeks). 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 NCT02280629, 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 27 Jan 2020.