Joint PainPhase 1NCT06444867
A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 158968
A Phase 1 study testing LEO 158968 in people with Joint Pain and Gout Flares, run by LEO Pharma at 3 sites in 3 countries.
Trial summary
The main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Joint Pain, Gout Flares, Joint Inflammation
- What is being tested?
- LEO 158968
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 7 Jan 2025to 18 Sep 2025
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Participants meeting the American College of Rheumatology (ACR/EULAR) 2015 gout criteria with a score ≥8.
- Presence of a gout flare for no longer than 96 hours prior to the baseline visit.
- In case of naïve or newly diagnosed participants, the presence of monosodium urate (MSU) crystals in synovial fluid will be evaluated and confirmed.
- At least 1 joint affected by acute gout (eg, ankle, foot, knee, toe). Participants may have oligoarticular gout, defined as >1 and <5 affected joints. However, participants with polyarticular gout are not eligible. In case the participant has more than one affected joint, the investigator should select the most symptomatic joint (most painful/with more inflammatory signs) for the study assessments (primary endpoint), and it will be identified as the 'index joint'.
- At screening and baseline (Day 1), a participant-reported joint pain at rest of ≥50 mm on a 0-100 mm VAS with pain intensity ≥2 using a 5-point Likert scale and at least 2 of the following criteria in the target joint:
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- participant-reported flare.
- participant-reported warm joint.
- participant-reported swollen joint.
- Body mass index: ≤40 kg/m², at screening.
- Participants on ULT (xanthine oxidase inhibitors, uricosuric agents) with no changes in therapy for at least 2 weeks before dosing.
- Male participants, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until all follow-up procedures are complete. Adequate contraception for the male participant (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the participant, is also acceptable.
- Participants with hypertension, cardiovascular disease, diabetes, or renal disorder are required to be on a stable dose and schedule, with no changes in therapy for at least 4 weeks before screening and baseline, are expected to remain on a stable regimen during trial participation, and the diseases are biologically and clinically controlled.
Who cannot join
- Use of specified pain relief medications, including systemic glucocorticoids, within 4 weeks before the baseline visit, and weak and strong opioids, colchicine, and nonsteroidal anti inflammatory drugs within 7 days before the baseline visit.
- Presence of an acute gout flare in more than 4 joints at the baseline visit.
- Received a live vaccine within 4 weeks before dosing or receiving a live vaccine during the trial.
- Other causes of acute or chronic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, and calcium pyrophosphate deposition disease), tophaceous gout, or evidence/suspicion of infectious/septic arthritis.
- History of malignancy within the past 5 years, with the exception of basal cell skin cancer, carcinoma-in-situ of the cervix, or low-risk prostate cancer after curative therapy.
- Known hypersensitivity to any components of the product.
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- Presence of active or recurrent bacterial, fungal, or viral infections within 15 days prior to the baseline visit, or presence of human immunodeficiency virus (HIV) infection, and hepatitis B and C infection.
- Presence of active or latent tuberculosis (to be determined by chest X-ray and a tuberculosis screening questionnaire).
- Uncontrolled clinically significant hematologic, pulmonary, endocrine, metabolic, gastrointestinal, central nervous system, or hepatic disease.
- Unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, myocardial infarction, cerebrovascular events, or rapid atrial fibrillation) in the last 3 months prior to screening, or a cardiac hospitalization within the 3 months prior to screening.
- Participants who have undergone major surgery within 2 weeks before the baseline visit or have an unhealed operation wound.
- The presence of any medical or psychological condition or laboratory results that, in the Investigator's opinion, might create a risk to the participants or the trial.
- History of alcohol or substance abuse within the 12 months prior to the baseline visit or any condition associated with poor compliance as judged by the Investigator.
- Clinically significant general pain or non-gout-related joint pain that would interfere with the participant's ability to accurately assess pain in the target joint, at the discretion of the Investigator.
- Current participation in any other interventional clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open-label, Phase 1b, Multi-site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following a Single Dose of LEO 158968 in Subjects With Gout Flares
The main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.
- Conditions
- Joint Pain, Gout Flares, Joint Inflammation
- Being tested
- LEO 158968
- Keywords
- LEO 158968
- Medical subject headings
- Arthralgia, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 158968Drug
SC injection
| Study group | Role | What they receive |
|---|---|---|
| LEO 158968 | Experimental | Participants with gout flares will receive a single SC dose of LEO 158968 on Day 1. Receives: Drug: LEO 158968 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 4
The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
Measured: Day 4
Secondary outcomes (7)
Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 8
The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
Measured: Day 8
Number of Participants with a ≥2-point Reduction in Patient-reported Pain Intensity Score as Assessed by the 5-point Likert
The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
Measured: Day 1 to Day 8
Number of Participants Experiencing a Change in Pain Intensity in Affected Joints as Assessed by the Visual Analog Scale (VAS) Pain Score
Measured: Baseline to Day 8
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
A TEAE is defined as any event not present prior to administration of the trial drug or any event already present that worsens in either severity or frequency following exposure to the trial drug. A serious AE (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires participant to be hospitalized, results in disability, is a congenital anomaly, is a medical condition not immediately life-threatening but that requires intensive treatment in emergency room or at home. Any clinically significant changes in physical examination findings and abnormal objective test findings (eg, laboratory, x-ray, ECG) will be recorded as AEs.
Measured: Baseline to Day 85
Number of Participants with LEO 158968 Anti Drug Antibodies (ADA) from Baseline to Day 85
Measured: Baseline to Day 85
Number of Participants with LEO 158968 ADA from Baseline to Day 29
Measured: Baseline to Day 29
Number of Participants Using Rescue Medications from Baseline to Day 8
Measured: Baseline to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start7 Jan 2025
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444867
- Sponsor's protocol ID
- LP0189-2318
- Other IDs
- 2023-508793-29-00, 2023
- Status last verified
- May 2026
- First submitted
- 30 May 2024
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1b, Multi-site Trial to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following a Single Dose of LEO 158968 in Subjects With Gout Flares
- ClinicalTrials.gov ID
- NCT06444867
- Acronym / sponsor ID
- LP0189-2318
- Conditions
- Joint Pain, Gout Flares, Joint Inflammation
- Keywords
- LEO 158968
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 6 Jun 2024 (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 main objective of the study is to evaluate the effect on pain of a single, subcutaneous (SC) dose of LEO 158968 in participants with gout flares.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 158968 | Experimental | Drug: LEO 158968Participants with gout flares will receive a single SC dose of LEO 158968 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Participants meeting the American College of Rheumatology (ACR/EULAR) 2015 gout criteria with a score ≥8.
- Presence of a gout flare for no longer than 96 hours prior to the baseline visit.
- In case of naïve or newly diagnosed participants, the presence of monosodium urate (MSU) crystals in synovial fluid will be evaluated and confirmed.
- At least 1 joint affected by acute gout (eg, ankle, foot, knee, toe). Participants may have oligoarticular gout, defined as >1 and <5 affected joints. However, participants with polyarticular gout are not eligible. In case the participant has more than one affected joint, the investigator should select the most symptomatic joint (most painful/with more inflammatory signs) for the study assessments (primary endpoint), and it will be identified as the 'index joint'.
Key exclusion criteria (15 listed)
- Use of specified pain relief medications, including systemic glucocorticoids, within 4 weeks before the baseline visit, and weak and strong opioids, colchicine, and nonsteroidal anti inflammatory drugs within 7 days before the baseline visit.
- Presence of an acute gout flare in more than 4 joints at the baseline visit.
- Received a live vaccine within 4 weeks before dosing or receiving a live vaccine during the trial.
- Other causes of acute or chronic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, and calcium pyrophosphate deposition disease), tophaceous gout, or evidence/suspicion of infectious/septic arthritis.
- History of malignancy within the past 5 years, with the exception of basal cell skin cancer, carcinoma-in-situ of the cervix, or low-risk prostate cancer after curative therapy.
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 |
|---|---|---|
| LEO 158968SC injection | Drug | LEO 158968 |
Primary outcome
Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 4
Time frame: Day 4
The 5-point Likert scale for pain intensity assesses the degree of pain experienced by a participant. The scale is scored from 0 (no pain) to 4 (severe pain).
7 secondary outcomes
Number of Participants with a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 8
Time frame: Day 8
Number of Participants with a ≥2-point Reduction in Patient-reported Pain Intensity Score as Assessed by the 5-point Likert
Time frame: Day 1 to Day 8
Number of Participants Experiencing a Change in Pain Intensity in Affected Joints as Assessed by the Visual Analog Scale (VAS) Pain Score
Time frame: Baseline to Day 8
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to Day 85
Number of Participants with LEO 158968 Anti Drug Antibodies (ADA) from Baseline to Day 85
Time frame: Baseline to Day 85
Number of Participants with LEO 158968 ADA from Baseline to Day 29
Time frame: Baseline to Day 29
Number of Participants Using Rescue Medications from Baseline to Day 8
Time frame: Baseline to Day 8
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 12 May 2026.
- Individual participant dataSharing planned: No
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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 Expert study director
LEO Pharma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 158968 in people with Joint Pain and Gout Flares, run by LEO Pharma at 3 sites in 3 countries.
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 13 inclusion and 15 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Netherlands, United Kingdom. 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. 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 a Patient-reported Pain Intensity Score of 0 or 1 as Assessed by the 5-point Likert Scale on Day 4 (time frame: Day 4). 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 12 May 2026.