Clinical trial NCT05838755: A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain
Official title: A Multicenter Randomized, Double-blind, 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 (DPNP) /NEPTUNE-17
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Keywords: Diabetes
Neuropathic pain
Diabetic Peripheral Neuropathic Pain (DPNP)
214221
GSK3858279
Efficacy
Safety
Pharmacokinetics
Tolerability
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter randomized, double-blind, 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 (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.


Eligibility criteria: Inclusion 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.

Exclusion 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.

Primary outcomes:
measure: Change from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the Numeric Rating Scale (NRS)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Occurrences of adverse events (AEs), serious AE (SAEs), and AEs of special interest (AESI)
timeFrame: Up to 27 weeks
measure: Number of participants with greater than or equal to (≥) grade 3 hematological/clinical chemistry abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE)
timeFrame: Up to 27 weeks
measure: Maximum concentration (Cmax) of GSK3858279
timeFrame: At Week 12
measure: The time required for GSK3858279 to reach Cmax (tmax) in the plasma
timeFrame: At Week 12
measure: Pre-dose (trough) concentration at the end of the dosing interval (Ctau) of GSK3858279
timeFrame: At Week 12
measure: Average concentration over a dosing interval (Cavg) of GSK3858279
timeFrame: At Week 12
measure: Area under the time-concentration curve (AUC) over the dosing interval (0-tau) (AUC[0-tau]) of GSK3858279
timeFrame: At Week 12
measure: Change from baseline in the Short-Form McGill Pain Questionnaire total score over time
timeFrame: Baseline and up to Week 27
measure: Change from baseline in the weekly average of average daily pain intensity over time, assessed on the NRS
timeFrame: Baseline and up to Week 27
measure: Number of participants with greater than or equal to (≥) 30 percentage (%) reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS
timeFrame: At Week 12
measure: Number of participants with greater than or equal to ≥ 50 % reduction from baseline in the weekly average of average daily pain intensity at Week 12, assessed on the NRS
timeFrame: At Week 12
Other outcomes:
Locations:
city: Anniston
country: United States
facility: GSK Investigational Site
state: Alabama
city: Surprise
country: United States
facility: GSK Investigational Site
state: Arizona
city: Cerritos
country: United States
facility: GSK Investigational Site
state: California
city: Lomita
country: United States
facility: GSK Investigational Site
state: California
city: Largo
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Waltham
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Williamsville
country: United States
facility: GSK Investigational Site
state: New York
city: Huntersville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Lancaster
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Cypress
country: United States
facility: GSK Investigational Site
state: Texas
city: DeSoto
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: McAllen
country: United States
facility: GSK Investigational Site
state: Texas
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Washington
city: New Westminster
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Beijing
country: China
facility: GSK Investigational Site
city: Guangzhou
country: China
facility: GSK Investigational Site
city: Harbin
country: China
facility: GSK Investigational Site
city: Luoyang
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Wuhan
country: China
facility: GSK Investigational Site
city: Yueyang
country: China
facility: GSK Investigational Site
city: Corbeil-Essonnes
country: France
facility: GSK Investigational Site
city: Mulhouse
country: France
facility: GSK Investigational Site
city: Bad Homburg
country: Germany
facility: GSK Investigational Site
city: Mainz
country: Germany
facility: GSK Investigational Site
city: Muenster
country: Germany
facility: GSK Investigational Site
city: Wallerfing
country: Germany
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Gunma
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Tochigi
country: Japan
facility: GSK Investigational Site
city: Tochigi
country: Japan
facility: GSK Investigational Site
city: Tochigi
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Bucheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Czestochowa
country: Poland
facility: GSK Investigational Site
city: Gdynia
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Katowice
country: Poland
facility: GSK Investigational Site
city: Skorzewo
country: Poland
facility: GSK Investigational Site
city: Sochaczew
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Stanger
country: South Africa
facility: GSK Investigational Site
city: A CoruNa
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: San SebastiAn De Los Rey
country: Spain
facility: GSK Investigational Site
city: Torrevieja Alicante
country: Spain
facility: GSK Investigational Site
city: Cannock
country: United Kingdom
facility: GSK Investigational Site
city: Liverpool
country: United Kingdom
facility: GSK Investigational Site
city: Teesside
country: United Kingdom
facility: GSK Investigational Site
city: West Yorkshire
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: