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An efficacy and safety study of LTG-321 in osteoarthritis
EU CTIS ID: 2026-525966-22-00
What this study is testing
To evaluate the efficacy of LTG-321 compared to placebo in treating pain associated with osteoarthritis of the knee
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must be 40 to 80 years of age inclusive, at the time of signing the informed consent.
- If female and of childbearing potential, is willing and able to follow contraceptive guidelines
- If male and sexually active with partner of childbearing potential, is willing and able to follow contraceptive guidelines
- s signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Is willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines and other study procedures, including proper utilization of the study diary, and to communicate meaningfully with study personnel in local language.
- Is willing to withdraw from any medication for osteoarthritis including, but not limited to, opioids, NSAIDs, COX-2 inhibitors, topical medication, and duloxetine until completion of the EOS visit.
You likely can't join if
- Has osteoarthritis of other major joints including, but not limited to, the nontarget knee, and the severity of pain, in the opinion of the investigator, could interfere with assessment of pain of the target knee.
- Has had nondiagnostic arthroscopy performed on the target knee joint within 180 days prior to screening, or diagnostic arthroscopy performed on the target knee joint within 90 days prior to screening.
- Has had intraarticular injection therapies to the target knee joint within 12 weeks prior to screening, or to any non-target joint within 6 weeks prior to screening.
- Is currently using opioids, including tramadol, on 2 or more occasions per week in any week over the 4 weeks prior to screening.
- Has signs and/or symptoms of significant cardiac disease in the 6 months prior to screening, including, but not limited to, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (unstable angina, myocardial infarction, cardiovascular thrombotic events, transient ischemic attacks, and stroke).
- Has an active malignancy or history of malignancy within the past 5 years, with exception of resected and cured basal cell carcinoma and squamous cell carcinoma of the skin.
See the full eligibility criteria
Who can join
- Must be 40 to 80 years of age inclusive, at the time of signing the informed consent.
- If female and of childbearing potential, is willing and able to follow contraceptive guidelines
- If male and sexually active with partner of childbearing potential, is willing and able to follow contraceptive guidelines
- s signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Is willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines and other study procedures, including proper utilization of the study diary, and to communicate meaningfully with study personnel in local language.
- Is willing to withdraw from any medication for osteoarthritis including, but not limited to, opioids, NSAIDs, COX-2 inhibitors, topical medication, and duloxetine until completion of the EOS visit.
- Agrees to take only the protocol-permitted medications from the start of the diary run-in phase through the EOS visit.
- Has a confirmed diagnosis of osteoarthritis of the knee based on the following criteria: a. Has had radiographs of both knees with a posterior-anterior, fixed-flexion view taken during the screening phase; b. Meets ACR clinical and radiographic diagnostic criteria; c. Has evidence of osteoarthritis of the knee with a KL grade of 2 or 3, determined through central reading.
- Has a history of knee pain on most days for at least 3 months prior to the start of the screening phase.
- The pain screening assessment scores assessed in the target knee are both ≥4.0 (on a 0-10 scale) at screening assessments (Visit 1a and Visit 1b).
- The pain screening assessment scores assessed in the target knee must be ≥2.0 points (out of 10) higher than the scores in the non-target knee at screening (Visit 1a and Visit 1b) and Day 1 pre-dose.
- The target knee WOMAC pain subscale scores are ≥4.0 (on a 0-10 scale) at both screening (Visit 1b) and Day 1 pre-dose assessments.
- Has pain scores during the diary run-in phase that meet the following criteria: a. Has recorded an Average Daily (NPRS) Pain score on at least 6 of the 7 days of the diary run-in phase. b. Has a mean Average Daily (NPRS) Pain score during the diary run-in phase that is ≥5.0 and ≤9.0.
- The standard deviation of Average Daily (NPRS) Pain scores during the diary run-in phase is ≤1.5.
- Has a BMI ≤38.0 kg/m2 at screening.
What rules you out
- Has osteoarthritis of other major joints including, but not limited to, the nontarget knee, and the severity of pain, in the opinion of the investigator, could interfere with assessment of pain of the target knee.
- Has had nondiagnostic arthroscopy performed on the target knee joint within 180 days prior to screening, or diagnostic arthroscopy performed on the target knee joint within 90 days prior to screening.
- Has had intraarticular injection therapies to the target knee joint within 12 weeks prior to screening, or to any non-target joint within 6 weeks prior to screening.
- Is currently using opioids, including tramadol, on 2 or more occasions per week in any week over the 4 weeks prior to screening.
- Has signs and/or symptoms of significant cardiac disease in the 6 months prior to screening, including, but not limited to, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (unstable angina, myocardial infarction, cardiovascular thrombotic events, transient ischemic attacks, and stroke).
- Has an active malignancy or history of malignancy within the past 5 years, with exception of resected and cured basal cell carcinoma and squamous cell carcinoma of the skin.
- Is pregnant, breast feeding, or planning to become pregnant during the time of participation in the study.
- Has a known allergy to sodium channel blockers or protocol-allowed rescue medication.
- Requires a walker or wheelchair for mobility (walking sticks are permitted).
- Has a lifetime history of OUD.
- Has a history of SUD (other than OUD) within the past 2 years.
- Currently has a comorbid condition other than osteoarthritis, known to be significantly associated with arthritis or joint pathology, including, but not necessarily limited to, autoimmune disease with significant joint involvement (e.g., rheumatoid arthritis or Paget’s disease); seronegative spondyloarthropathies (e.g., ankylosing spondylitis, psoriasis arthritis, reactive arthritis); or other systemic disease involving the target knee (including endocrinopathies).
- Has a history of suicidal plan or intent within 2 years of screening and/or current suicidal ideation, as assessed by the investigator.
- Has any comorbid psychiatric disorder causing ongoing, marked psychiatric distress that, in the opinion of the investigator, would interfere with accurate reporting of physical pain symptoms.
- Has an unmanaged sleep disorder with persistent insomnia that, in the opinion of the investigator, would interfere with accurate reporting of physical pain symptoms.
- Has moderate or severe hepatic impairment based on clinical judgement, in the opinion of the investigator, or meets diagnostic criteria based on ALT and AST laboratory values outlined in exclusion #33.
- Has previously used Journavx (suzetrigine) or any other NaV1.8 inhibitor.
- Is currently using a moderate or strong CYP3A4 inhibitor or inducer that cannot be discontinued, or is not able to follow the guidance for restricted medications throughout the study
- Is currently taking medications that have been shown to cause Torsade de Pointes. Participants taking medications that are suspected to prolong QT interval must be on a stable regimen and must not have plans to change those medications during the study.
- Is currently using any other investigational drugs or devices that cannot be discontinued or is not able to follow the guidance for restricted medications throughout the study
- Has participated in a previous study investigating LTG-321.
- Has participated in another investigational study within 30 days (or 90 days for biologics) prior to screening.
- Has osteoarthritis or other potentially serious joint pathology in any joint that is deemed rapidly progressive.
- Is a male participant with ECG QTcF >450 msec or female participant with ECG QTcF >470 msec (applying Fridericia correction), defined as the mean of the QTcF of triplicate ECGs obtained in rapid succession. Participants using allowable concomitant medications that are known or suspected to prolong QT interval (consistent with exclusion #26) will be excluded if their QTcF >430 ms.
- Has clinically significant abnormal laboratory parameter(s) and/or ECG parameter(s) during screening, that, in the judgment of the investigator, would preclude the participant from participation in this study.
- Has an eGFR of <45 mL/min/1.73 m2 at screening.
- Has ALT or AST values >1.5× ULN at screening.
- Has any other abnormal laboratory results indicative of significant medical disease that, in the opinion of the investigator, would preclude the participant’s participation in the study.
- Has a positive urine drug screen, other than for a known prescribed concomitant medication that is not otherwise exclusionary (e.g., benzodiazepines).
- Is, or has a close relative that is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved with the conduct of the study at that site.
- Has a history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug.
- Meets any other lifestyle, medication, or other study restrictions.
- Has a hip dislocation and congenital hip dysplasia with degenerative joint disease.
- Has a history of gout with recent (i.e., <6 months) pain flares and uncontrolled uric acid levels. Participants with a history or diagnosis of pseudogout (calcium pyrophosphate dihydrate crystal deposition disease) can enroll if there has not been a flare within the 6 months prior to screening and use of NSAIDs is not required for management of this condition.
- Has any chronic pain condition besides osteoarthritis for which they have taken medication in the past year, including neuropathic pain, complex regional pain syndrome, chronic widespread pain syndromes (e.g., fibromyalgia), chronic low back pain, and migraine.
- Has a history of significant trauma (e.g., intra-articular fracture) or major surgery (excluding injection therapies and arthroscopy) to a knee, hip, or shoulder within the previous 1 year.
- Has planned a major surgery or other major invasive procedure while participating in the study.
- Has had surgery or stent placement for coronary artery disease in the 6 months prior to screening.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.