OsteoarthritisPhase 1NCT04564053
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
A Phase 1 study testing LNA043 in people with Osteoarthritis and Knee, run by Novartis Pharmaceuticals at 2 sites in Japan.
Trial summary
The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- LNA043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesJapan
- Study dates
- 23 Sep 2020to 10 Dec 2020
- Phase
- Phase 1
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Japanese participants aged 20 to 80 years at screening
- A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
- Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).
Who cannot join
- Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
- Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
- Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
- Malalignment >10° in the target knee (varus/valgus)
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Novartis Investigative Site
Osaka, 532-0003
Novartis Investigative Site
Shinjuku-ku, Tokyo, 162-0053
About this study
Official title: A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee
The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.
Read the detailed description
This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.
- Conditions
- Osteoarthritis, Knee
- Being tested
- LNA043, Placebo
- Keywords
- osteoarthritis, knee, cartilage
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNA043Drug
Single intra-articular injection on Day 1
PlaceboDrug
Single intra-articular injection on Day 1
| Study group | Role | What they receive |
|---|---|---|
| LNA043 | Experimental | LNA043 Receives: Drug: LNA043; Drug: Placebo |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Measured: Up to Day 22
Secondary outcomes (3)
Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration
To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Measured: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Observed maximum serum concentration of LNA043
To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Measured: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Number of participants with anti-LNA043 antibodies in serum
To assess systemic immunogenicity of LNA043 (anti-LNA043 antibodies) following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Measured: Day 1 (pre-dose), 4, 8, 15, 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start23 Sep 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564053
- Sponsor's protocol ID
- CLNA043A11101
- Status last verified
- Aug 2022
- First submitted
- 23 Sep 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04564053
- Acronym / sponsor ID
- CLNA043A11101
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, cartilage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 25 Sep 2020 (actual)
- 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 objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.
Detailed description
This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.
| Arm | Type | Receives |
|---|---|---|
| LNA043 | Experimental | Drug: LNA043, Drug: PlaceboLNA043 |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female Japanese participants aged 20 to 80 years at screening
- A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening
- Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).
Key exclusion criteria (4 listed)
- Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.
- Arthroscopy of the target knee within 6 months prior to Screening or planned during the study
- Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening
- Malalignment >10° in the target knee (varus/valgus)
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 |
|---|---|---|
| LNA043Single intra-articular injection on Day 1 | Drug | LNA043 |
| PlaceboSingle intra-articular injection on Day 1 | Drug | LNA043, placebo |
Primary outcome
Number of participants with adverse events
Time frame: Up to Day 22
To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
3 secondary outcomes
Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration
Time frame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Observed maximum serum concentration of LNA043
Time frame: 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose
Number of participants with anti-LNA043 antibodies in serum
Time frame: Day 1 (pre-dose), 4, 8, 15, 22
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 10 Aug 2022.
- A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LNA043 in people with Osteoarthritis and Knee, run by Novartis Pharmaceuticals at 2 sites in Japan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with adverse events (time frame: Up to Day 22). 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 10 Aug 2022.