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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05454020




Registration number
NCT05454020
Ethics application status
Date submitted
16/06/2022
Date registered
12/07/2022
Date last updated
9/05/2023

Titles & IDs
Public title
A Study of Topical XG004 in Participants With Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
PR-XG004-03-OA-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - XG004
Treatment: Drugs - Placebo

Experimental: A (XG004) - XG004 in two dose level (5% or 10%) will be applied to the targeted knee

Placebo Comparator: B (Placebo) - Placebo in all cohorts will be applied to the targeted knee.


Treatment: Drugs: XG004
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.

Treatment: Drugs: Placebo
Placebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline to end of treatment up to 14 days
Secondary outcome [1] 0 0
To examine skin response
Timepoint [1] 0 0
From day 1 to day 8
Secondary outcome [2] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
Timepoint [2] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [3] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments.
Timepoint [3] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [4] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Timepoint [4] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [5] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Timepoint [5] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [6] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Timepoint [6] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [7] 0 0
To evaluate systemic pharmacokinetic (PK) following topical administration to the knee. Blood will be collected for plasma PK assessments
Timepoint [7] 0 0
From baseline to end of treatment up to 8 days
Secondary outcome [8] 0 0
To explore the penetration of XG004 into the synovial fluid of the knee. Synovial fluid samples will be evaluated for the drug concentrations.
Timepoint [8] 0 0
Day 8

Eligibility
Key inclusion criteria
1. Participant must be 40 to 75 years of age inclusive, at the time of signing the
informed consent form.

2. Body Mass Index (BMI) of 18 to 39, inclusive, at the time of Screening visit.

3. 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.

4. 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.

5. 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. Participants with any report of acute illness or febrile event within 72 hours prior
to randomization.

8. 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.

9. Participants who cannot refrain from strenuous exercise from 72 hours prior to first
study dose through completion of the Safety follow-up visit

10. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/03/2023
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC Clinical research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Xgene Pharmaceutical Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05454020
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Guy Ludbrook
Address 0 0
PARC Clinical research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries