A Study of Topical XG004 in Participants With Osteoarthritis of the Knee

NCT05454020 | Completed Phase 1 DMC

• 1 other identifier: PR-XG004-03-OA-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

  From baseline to end of treatment up to 14 days

Secondary Outcomes (8)

• To examine skin response

  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.

  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.

  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

  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

  From baseline to end of treatment up to 8 days

Study Arms (2)

A (XG004)

EXPERIMENTAL

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

Drug: XG004

B (Placebo)

PLACEBO COMPARATOR

Placebo in all cohorts will be applied to the targeted knee.

Drug: Placebo

Interventions

XG004 DRUG

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.

A (XG004)

Placebo DRUG

Placebo gel will be applied topically once-daily, twice-daily or three times daily in a designated area of the study knee.

B (Placebo)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Xgene Pharmaceutical Group: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

PARC Clinical research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Ludbrook

  PARC Clinical research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 12, 2022
• Study Start: June 7, 2022
• Primary Completion: January 23, 2023
• Study Completion: March 21, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

AU (1)