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Tests treatment safety and results for Osteoarthritis in the Knee
Official title Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis
ClinicalTrials.gov ID: NCT06833749
What this study is testing
What is KBP-336?
KBP-336 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for osteoarthritis in the knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if KBP-336 works to treat pain in osteoarthritis in individuals living with obesity. It will also learn about the effects on other parameters, such as quality of life and metabolism, as well as safety of KBP-336.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- The participant is able to read and understand the language and content of the study material and provide written Informed Consent.
- Willing and able to comply with study requirements and instructions
- A diagnosis of OA of the target knee based on American College of Rheumatology (ACR) clinical and radiographic criteria(31), with OA symptoms (as...
- Radiological OA grade 2 or 3 of the target knee, using the Kellgren-Lawrence method as graded by a central reader on a Fixed-Flexion X-ray obtained...
- Age ≥ 45 years of either sex
You likely can't join if
- Partial or complete joint replacement of either knee
- Target knee surgery or arthroscopy within 1 year prior to screening
- Diagnosis of OA resulting from trauma within the last 5 years
- Pain of the contralateral knee exceeding that of the target knee at the baseline visit, as measured by the WOMAC pain subscale
- Planned major surgery within the next 6 months
- Uncontrolled thyroid disease in the opinion of the Investigator based on medical history and laboratory results collected in screening
See the full eligibility criteria
Who can join
- The participant is able to read and understand the language and content of the study material and provide written Informed Consent.
- Willing and able to comply with study requirements and instructions
- A diagnosis of OA of the target knee based on American College of Rheumatology (ACR) clinical and radiographic criteria(31), with OA symptoms (as reported by the participant) that have been present for at least 3 months...
- Radiological OA grade 2 or 3 of the target knee, using the Kellgren-Lawrence method as graded by a central reader on a Fixed-Flexion X-ray obtained during screening, or on a recent (within 6 months) X-ray which fulfills...
- Age ≥ 45 years of either sex
- Body Mass Index (BMI) ≥ 30 kg/m2
- Good health, defined as no significantly relevant medical history or findings on physical examination, vital signs, ECG, and laboratory results in the opinion of the investigator.
- Intolerance or insufficient pain relief with standard of care (e.g. physiotherapy, paracetamol, local or systemic NSAID, short term opioid use, injections of hyaluronic acid, or corticosteroids) for symptomatic OA in...
- WOMAC pain subscale score in target knee at screening AND baseline ≥20 (0-50 scale)
- Willing to withdraw from any pain medication including, but not limited to, Opioids (including semisynthetic opioids), Non-Steroidal Anti-inflammatories (NSAIDs, with the exception of low-dose aspirin for...
What rules you out
- Partial or complete joint replacement of either knee
- Target knee surgery or arthroscopy within 1 year prior to screening
- Diagnosis of OA resulting from trauma within the last 5 years
- Pain of the contralateral knee exceeding that of the target knee at the baseline visit, as measured by the WOMAC pain subscale
- Planned major surgery within the next 6 months
- Uncontrolled thyroid disease in the opinion of the Investigator based on medical history and laboratory results collected in screening
- Participant-reported weight loss \>5% of body weight within the last 6 months of the screening visit
- Bariatric surgery within the last 12 months of the screening visit
- Current comorbid condition, other than OA, affecting target knee or systemic illness known to be significantly associated with arthritis or joint pathology affecting any joint, including but not necessarily limited to...
- Conditions significantly affecting joint and bone health, in the opinion of the Investigator should be excluded (including but not limited to atrophic or hypotrophic OA, subchondral insufficiency fracture...
- Active comorbid condition other than OA (e.g radicular back pain, bursitis, tendinitis) significantly affecting target knee pain reporting in the opinion of the investigator.
- A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at screening
- History of gout, or pseudogout, with high likelihood of flare up during trial participation that would require NSAID treatment, in the opinion of the investigator
- Hip dislocation and congenital hip dysplasia with degenerative joint disease should be excluded.
- Participation in any previous DACRA/amylin study
- History or presence of clinically significant neurological disease or psychiatric disorder in the opinion of the investigator
- Intra-articular injection of corticosteroids within 3 months or hyaluronic acid within 6 months of screening in the target knee or into any other major joint within 30 days prior to screening (for extended-release...
- Systemic corticosteroid treatment for the treatment of musculoskeletal conditions of more than 14 days during the past 6 months prior to screening.
- Any pharmacological or non-pharmacological treatment primarily targeting OA started or changed during the 4 weeks prior to randomization or likely to be changed during the duration of the study
- Treatment with medication for obesity, including GLP-1 analogues, unless the dose of use has been stable for at least six months prior to screening
- Vitamin D deficiency defined as blood 25-OH D3 concentration ≤25 nmol/L. Vitamin D supplementation and subsequent rescreening is allowed
- Presence or history of clinically significant allergies, including relevant drug hypersensitivity or allergy
- Current malignancy or treatment for malignancy within the past five years, apart from resected basal cell carcinoma, squamous skin cell carcinoma, or resected cervical atypia or carcinoma in situ, unless affecting the...
- History of alcohol or drug abuse within 5 years prior to screening, in the opinion of the Investigator.
- Use of an investigational drug within 90 days prior to screening
- For women of childbearing potential:
- Pregnancy (i.e. positive serum pregnancy test at screening) or breastfeeding
- Failure to agree to practice a highly effective method of contraception (see Appendix 2), from enrolment up to at least 3 months after the study end
- For sexually active men with a female partner of childbearing potential:
- Failure to agree to ensure that their female partners use a highly effective method of contraception (see Appendix 2) from enrolment up to at least 3 months after the study end
- Failure to agree not to donate sperm throughout the study and at least 3 months after the study end
- Unsuitable for study participation for any reason in the opinion of the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Brno, Czechia
- Hlučín, Czechia
- Hradiště, Czechia
- Pardubice, Czechia
- Prague, Czechia
- Gandrup, Denmark
- Herlev, Denmark
- Vejle, Denmark
- Hong Kong, Hong Kong
- Chisinau, Moldova
- Bytom, Poland
- Poznan, Poland
- Swidnica, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Bucharest, Romania
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, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, Czechia; Hlučín, Czechia; Hradiště, Czechia; Pardubice, Czechia; Prague, Czechia; Gandrup, Denmark and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.