PainPhase 1NCT05454020
A Study of Topical XG004 in Participants With Osteoarthritis of the Knee
A Phase 1 study testing XG004 in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
Trial summary
This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- XG004
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Jun 2022to 21 Mar 2023
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent form.
- Body Mass Index (BMI) of 18 to 39, inclusive, at the time of Screening visit.
- Participant who is diagnosed with primary knee OA fulfilling the American College of Rheumatology (ACR) Clinical and Radiographic criteria for ≥ 26 weeks prior to Screening visit.
- Kellgren-Lawrence Grade II to IV as confirmed by X-ray during Screening visit or within 6 months prior to Screening visit in the study knee.
- The average daily walking pain scale in the study knee over Day -4 to Day -2 during the Baseline period must be ≥ 4.0 on NRS 0-10 scale.
Who cannot join
- Participants with any systemic or dermatological disorder that may interfere with the evaluation of the test site reactions (e.g., atopic dermatitis, contact eczema, psoriasis).
- Participants with scars, moles, tattoos at application site or other abnormal pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results.
- Participants with any of the following conditions on the test area: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, acne vulgaris, atrophic skin, striae atrophic, fragility of skin veins, ichthyosis, ulcers or wounds.
- Participants exposed to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, solarium); and waxing, laser/IPL hair removal, fake/spray tanning is prohibited 14 days prior to enrollment or who may foresee an intensive UV exposure or swimming during study participation.
- Known hypersensitivity or allergy to NSAIDs or gabapentinoids or any component(s) of the investigational products. This includes participants exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
- Participants with unstable or severe illness, including clinically significant malignancy, of hepatic, pulmonary, metabolic, neurologic, cardiovascular, gastrointestinal (e.g., inflammatory bowel disease), hematological, or psychiatric system as indicated on medical history, physical examination, or clinical laboratory, vital signs, and ECG evaluations, or in the opinion of the Investigator.
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- Participants with any report of acute illness or febrile event within 72 hours prior to randomization.
- Known positive coronavirus disease 2019 (COVID-19) viral test during Screening or within 3 days prior to Day -1, or suspected COVID-19 infection at check-in on Day -1 visit.
- Participants who cannot refrain from strenuous exercise from 72 hours prior to first study dose through completion of the Safety follow-up visit
- Any other condition that, in the opinion of the investigator, would jeopardize the safety of the study participant or impact the validity of the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants With Osteoarthritis of the Knee
This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee
Read the detailed description
The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day Safety follow-up period that will be conducted by telephone for each Cohort.
Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and assigned treatment on a 3:1 (XG004: placebo) ratio.
- Conditions
- Pain
- Being tested
- XG004, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XG004Drug
XG004 gel in two concentrations (5% and 10%) will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.
PlaceboDrug
Placebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.
| Study group | Role | What they receive |
|---|---|---|
| A (XG004) | Experimental | XG004 in two dose level (5% or 10%) will be applied to the targeted knee Receives: Drug: XG004 |
| B (Placebo) | Placebo comparator | Placebo in all cohorts will be applied to the targeted knee. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0
Measured: From baseline to end of treatment up to 14 days
Secondary outcomes (8)
To examine skin response
Skin safety and irritability assessment will be conducted after topical application of investigational product. All skin reactions at the applications sites will be examined and scored as per Modified Berger/Bowman Scoring Scale.
Pain will be examined a 0-10 NRS (numerical rating scale) and higher scores mean a worse outcome.
Measured: From day 1 to day 8
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
The following parameter is used for evaluation during PK assessments: Maximum concentration (Cmax)
Measured: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
The following parameter is used for evaluation during PK assessments: Time to maximum concentration (Tmax)
Measured: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Area under the drug concentration-time curve
Measured: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: accumulation ratio (AR)
Measured: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Apparent clearance
Measured: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
The following parameter is used for evaluation during PK assessments: Apparent terminal half-life
Measured: From baseline to end of treatment up to 8 days
To explore the penetration of XG004 into the synovial fluid of the knee. Synovial fluid samples will be evaluated for the drug concentrations.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Jun 2022
- Primary completion23 Jan 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xgene Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Guy Ludbrook, Principal investigator, PARC Clinical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454020
- Sponsor's protocol ID
- PR-XG004-03-OA-01
- Status last verified
- May 2023
- First submitted
- 16 Jun 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dosing, Ascending-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of XG004 Applied Topically in Participants With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT05454020
- Acronym / sponsor ID
- PR-XG004-03-OA-01
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Xgene Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 12 Jul 2022 (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.
This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee
Detailed description
The study will consist of a 4-week Screening period, an 7-day Treatment period and a 7-day Safety follow-up period that will be conducted by telephone for each Cohort.
Up to 32 participants with OA of the knee will be enrolled into 6 cohorts sequentially and assigned treatment on a 3:1 (XG004: placebo) ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (XG004) | Experimental | Drug: XG004XG004 in two dose level (5% or 10%) will be applied to the targeted knee |
| B (Placebo) | Placebo comparator | Drug: PlaceboPlacebo in all cohorts will be applied to the targeted knee. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent form.
- Body Mass Index (BMI) of 18 to 39, inclusive, at the time of Screening visit.
- Participant who is diagnosed with primary knee OA fulfilling the American College of Rheumatology (ACR) Clinical and Radiographic criteria for ≥ 26 weeks prior to Screening visit.
- Kellgren-Lawrence Grade II to IV as confirmed by X-ray during Screening visit or within 6 months prior to Screening visit in the study knee.
- The average daily walking pain scale in the study knee over Day -4 to Day -2 during the Baseline period must be ≥ 4.0 on NRS 0-10 scale.
Key exclusion criteria (10 listed)
- Participants with any systemic or dermatological disorder that may interfere with the evaluation of the test site reactions (e.g., atopic dermatitis, contact eczema, psoriasis).
- Participants with scars, moles, tattoos at application site or other abnormal pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results.
- Participants with any of the following conditions on the test area: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, acne vulgaris, atrophic skin, striae atrophic, fragility of skin veins, ichthyosis, ulcers or wounds.
- Participants exposed to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, solarium); and waxing, laser/IPL hair removal, fake/spray tanning is prohibited 14 days prior to enrollment or who may foresee an intensive UV exposure or swimming during study participation.
- Known hypersensitivity or allergy to NSAIDs or gabapentinoids or any component(s) of the investigational products. This includes participants exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
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 |
|---|---|---|
| XG004XG004 gel in two concentrations (5% and 10%) will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee. | Drug | A (XG004) |
| PlaceboPlacebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee. | Drug | B (Placebo) |
Primary outcome
To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0
Time frame: From baseline to end of treatment up to 14 days
8 secondary outcomes
To examine skin response
Time frame: From day 1 to day 8
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Time frame: From baseline to end of treatment up to 8 days
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Time frame: From baseline to end of treatment up to 8 days
To explore the penetration of XG004 into the synovial fluid of the knee. Synovial fluid samples will be evaluated for the drug concentrations.
Time frame: 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 9 May 2023.
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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.
Guy Ludbrook principal investigator
PARC Clinical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XG004 in people with Pain, run by Xgene Pharmaceutical Group at 1 site in Australia.
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 5 inclusion and 10 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
To evaluate the safety and tolerability of topical XG004 applied to the study knee in Osteoarthritis (OA) participants through incidence of Treatment Emergent Adverse Events as assessed by CTCAE v5.0 (time frame: From baseline to end of treatment up to 14 days). 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 May 2023.