A placebo-controlled Phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (NEPTUNE-17)

JRCT ID: jRCT2031230412

Registered date:18/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic diabetic peripheral neuropathic pain
• Date of first enrollment: 28/10/2023
• Target sample size: 240
• Countries of recruitment: Germany,Japan,Poland,Japan,United Kingdom,Japan,Canada,Japan,United States,Japan,France,Japan,Spain,Japan,China,Japan,Korea,Japan,South Africa,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

-GSK3858279(2 doses)
-Placebo
This study consists of 3 study arms (Placebo arm and GSK3858279 dose1~2 arms).

Outcome(s)

• Primary Outcome: Change from baseline at Week 12 in weekly average of average daily knee pain intensity, assessed on the Numeric Rating Scale (NRS)

Secondary Outcome

- Occurrence of AEs, SAEs and AEs of Special Interest (AESIs)
- Occurrence of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade >-3 hematological/clinical chemistry abnormalities
- Maximum value (Cmax), time of Cmax (tmax), trough value (Ctau), average concentration (Cavg) and area under the curve over the dosing interval (AUC(0-tau)) after the last planned dose
- Change from baseline in the Short-Form McGill Pain Questionnaire total score over time
- Change from baseline in the weekly average of average daily pain intensity over time, assessed on the NRS
- Occurrence of >-30% reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS
- Occurrence of >-50% reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

-Participant must be 18-75 years of age inclusive, at the time of signing the informed consent.
-Type I or Type II diabetes with painful, distal, symmetrical, sensory motor neuropathy attributed to diabetes, of at least 6 months duration.
-A pain score >-4 and less than or equal to (<-) 9 by the 11-point NRS (0-10) for average daily pain intensity over the past 24 hours at the screening visit.
-Body mass index (BMI) within the range 18-40 kilogram per meter square (kg/m^2)(inclusive)
-Capable of giving signed informed consent.

Exclude criteria

-History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
-Participant has current painful peripheral neuropathy due to a cause other than diabetes (e.g. pernicious anemia, hypothyroidism, post-herpetic neuralgia).
-History of significant allergies to monoclonal antibodies.
-Current enrolment or past participation in a clinical study of an investigational medicinal product intervention within the last 30 days or 5 half-lives (whichever is longer) of signing consent.
-Participants who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits, inability to complete the eDiary daily etc.) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Related Information

• Primary Sponsor: Okawa Yasutoshi
• Secondary ID(s): NCT05838755