Relapsing Remitting Multiple SclerosisPhase 3LIBRETTONCT01975298
A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 3 study testing Laquinimod and Avonex® in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial summary
The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of laquinimod compared to Avonex® Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Laquinimod and Avonex®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2014
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
- Subjects must be ambulatory with an Kurtzke EDSS score of 0-5.5 at both Screening and Baseline (randomization) visits.
- Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment (intravenous [IV], IM and/or per os [PO]) or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
- Subjects must have experienced at least 1 documented relapse in the last year prior to randomization or 2 relapses in the last 3 years prior to randomization.
- Subjects must be between 18 and 55 years of age at screening, inclusive.
- Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barrier method [condom or diaphragm with spermicide]).
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- Subjects must be able to sign and date a written informed consent prior to entering the study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- other criteria may apply, please contact the investigator for more information
Who cannot join
- Subjects with progressive forms of MS.
- Subjects with Neuromyelitis Optica (NMO).
- Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to Baseline visit (randomization).
- Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azatioprine within 12 months prior to Baseline.
- Natalizumab (Tysabri®) if given more than 6 months prior to randomization AND the subject is John Cunningham (JC) virus antibody test negative at Screening.
- Previous use of Rituximab, ocrelizumab, or ofatumumab is allowed if the B cell count (CD19) is higher than 80 cells /μL.
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- Previous treatment with glatiramer acetate (Copaxone®e), fingolimod (Gilenya®), BG-12 (Tecfidera), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG) within 2 months prior to Baseline.
- Use of mitoxantrone (Novantrone) within 5 years prior to Screening. Use of mitoxantrone (Novantrone) >5 years before screening is allowed in subjects with normal ejection fraction and who did not exceed the total lifetime maximal dose.
- Chronic (more than 30 consecutive days or monthly dosing, eg, with the intent of MS disease modification) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to Baseline.
- Previous use of cladribine.
- Previous use of laquinimod or Avonex® IM.
- Treatment with other Interferon-β (either 1a subcutaneous [SC] or 1b SC) within 60 days before baseline (earlier treatment will be allowed if the reason for discontinuation was not treatment failure or for Interferon-β related safety reasons. This decision will be taken by the investigator).
- Previous total body irradiation or total lymphoid irradiation.
- Previous stem cell treatment, autologous bone marrow transplantation, or allogenic bone marrow transplantation.
- Acute infection within 2 weeks prior to Baseline visit.
- Major trauma or surgery within 2 weeks prior to Baseline visit.
- Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to Baseline.
- Use of inducers of CYP3A4 within 2 weeks prior to Baseline
- Pregnancy or breast feeding.
- Serum levels ≥ 3 times (x) upper limit of normal (ULN) of either ALT or AST at Screening.
- Serum direct bilirubin ≥ 2xULN at Screening.
- Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests MRI or chest X-ray
- Any acute pulmonary disorder.
- A central nervous system disorder other than MS that may jeopardize the participation in the study, including such disorders that are demonstrated on the baseline MRI.
- A gastrointestinal disorder that may affect the absorption of study medication.
- Renal disease.
- Thyroid disease: hyperthyroidism, hypothyroidism.
- Any form of acute or chronic liver disease.
- Known human immunodeficiency virus positive status.
- A clinical history of drug and/or alcohol abuse.
- Unstable psychiatric disorder.
- A history of seizure disorder, with the last convulsive episode within 12 months prior to Screening visit.
- Any malignancies, excluding basal cell carcinoma, in the 5 years prior to randomization.
- Twenty or more gadolinium - enhancing lesions on baseline MRI.
- A known history of sensitivity to gadolinium (Gd).
- GFR ≤ 60 mL/min at the screening visit.
- Inability to successfully/safely undergo MRI scanning.
- Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
- Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine, or sodium stearyl fumarate.
- A known history of hypersensitivity to natural or recombinant interferon β, human albumin, or any other component of the formulation of Avonex®
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- other criteria may apply, please contact the investigator for more information
About this study
Official title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of laquinimod compared to Avonex®
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Laquinimod, Avonex®
- Keywords
- RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaquinimodDrug
Also called TV-5600
Oral Administration
Avonex®Drug
Also called Interferon β1A
Interferon β1A 30 μg/0.5mL administered Intra Muscular
| Study group | Role | What they receive |
|---|---|---|
| Laquinimod 0.6 mg | Experimental | Not described Receives: Drug: Laquinimod |
| Laquinimod 1.2 mg | Experimental | Not described Receives: Drug: Laquinimod |
| Avonex® | Active comparator | Not described Receives: Drug: Avonex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Atrophyas observed by Magnetic Resonance Imaging (MRI)
This is assessed by an MRI and is a measure of brain volume
Measured: Baseline and Month 12.
Secondary outcomes (3)
The cumulative number of reported influenza-like symptoms
Measured: Baseline to Month 3
Cumulative number of new T2 lesions observed by Magnetic Resonance Imaging (MRI) between the 2 laquinimod doses
Measured: Baseline, Month 6 and Month 12
Summary of Participant with Adverse Events
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975298
- Sponsor's protocol ID
- LAQ-MS-306
- Other IDs
- 2013-002082-19
- Acronym
- LIBRETTO
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2013
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
- ClinicalTrials.gov ID
- NCT01975298
- Acronym / sponsor ID
- LIBRETTO / LAQ-MS-306
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- RRMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Nov 2013 (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 the study is to assess the efficacy, safety, and tolerability of two doses of laquinimod compared to Avonex®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laquinimod 0.6 mg | Experimental | Drug: Laquinimod |
| Laquinimod 1.2 mg | Experimental | Drug: Laquinimod |
| Avonex® | Active comparator | Drug: Avonex® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
- Subjects must be ambulatory with an Kurtzke EDSS score of 0-5.5 at both Screening and Baseline (randomization) visits.
- Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment (intravenous [IV], IM and/or per os [PO]) or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
- Subjects must have experienced at least 1 documented relapse in the last year prior to randomization or 2 relapses in the last 3 years prior to randomization.
- Subjects must be between 18 and 55 years of age at screening, inclusive.
Key exclusion criteria (42 listed)
- Subjects with progressive forms of MS.
- Subjects with Neuromyelitis Optica (NMO).
- Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to Baseline visit (randomization).
- Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azatioprine within 12 months prior to Baseline.
- Natalizumab (Tysabri®) if given more than 6 months prior to randomization AND the subject is John Cunningham (JC) virus antibody test negative 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 |
|---|---|---|
| LaquinimodAlso: TV-5600Oral Administration | Drug | Laquinimod 0.6 mg, Laquinimod 1.2 mg |
| Avonex®Also: Interferon β1AInterferon β1A 30 μg/0.5mL administered Intra Muscular | Drug | Avonex® |
Primary outcome
Brain Atrophyas observed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and Month 12.
This is assessed by an MRI and is a measure of brain volume
3 secondary outcomes
The cumulative number of reported influenza-like symptoms
Time frame: Baseline to Month 3
Cumulative number of new T2 lesions observed by Magnetic Resonance Imaging (MRI) between the 2 laquinimod doses
Time frame: Baseline, Month 6 and Month 12
Summary of Participant with Adverse Events
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
Medical Director, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Laquinimod and Avonex® in people with Relapsing Remitting Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc..
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 9 inclusion and 42 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: withdrawn, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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 withdrawn before enrolling participants, so there are no results.
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?
Brain Atrophyas observed by Magnetic Resonance Imaging (MRI) (time frame: Baseline and Month 12.). 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 9 Nov 2021.