A Study to Evaluate Efficacy and Safety of GSK3858279 in Diabetic Peripheral Neuropathic Pain

NCT05838755 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2142212022-502313-28-00
• Study Type: interventional
• Target: 147
• Locations: 11 countries
• Sites: 81

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.

Conditions

Pain

Keywords

Diabetes; Neuropathic pain; Diabetic Peripheral Neuropathic Pain (DPNP); 214221; GSK3858279; Efficacy; Safety; Pharmacokinetics; Tolerability

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Weekly Average of Average Daily Pain Score at Week 12, Assessed on the Numeric Rating Scale (NRS)

  The change from baseline (CFB) in the weekly average of the average daily pain score at Week 12 was assessed using Numeric Rating Scale (NRS). Participants recorded their average daily pain response daily using a Brief Pain Inventory Item 5. It is a single item designed for self-reporting average pain score for past 24 hours. Participants were asked to mark their average pain intensity daily, using the NRS, on an 11-point scale (0 = no pain, 10 = worst pain imaginable). The weekly average was computed as weekly average of the average daily scores (range: 0-10), where higher scores indicate more severe pain. A negative CFB indicates pain improvement. Baseline was defined as the average score over the 7 days before dosing (Day -7 to -1). Posterior mean CFB and the 95% credible interval were derived using a Bayesian mixed model repeated measures analysis. The data presented as "Mean" refers to the 'posterior mean' and "95% confidence interval" to '95% credible interval'.

  Baseline (Day -7 to Day -1) and Week 12

Secondary Outcomes (11)

• Number of Participants With Adverse Events (AEs), Serious AE (SAEs) and AEs of Special Interest (AESI)

  Up to 27 weeks

• 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 (NCI-CTCAE)

  Up to 27 weeks

• Maximum Concentration (Cmax) of GSK3858279

  Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose

• Time to Maximum Concentration (Tmax) of GSK3858279

  Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose

• Trough Concentration at the End of the Dosing Interval (Ctau) of GSK3858279

  Pre-dose, Week 1, Week 4, Week 7, Week 8, Week 11, Week 12, Week 16, Week 20 and Week 27 post dose

Study Arms (3)

GSK3858279 60 mg

EXPERIMENTAL

Participants received GSK3858279 SC injection 60 milligram (mg) once per week for 12 weeks.

Drug: GSK3858279

GSK3858279 360 mg

EXPERIMENTAL

Participants received GSK3858279 SC injection 360 mg once per week for 12 weeks.

Drug: GSK3858279

Placebo

PLACEBO COMPARATOR

Participants received matching placebo subcutaneous (SC) injection once per week for 12 weeks.

Drug: Placebo

Interventions

GSK3858279 DRUG

GSK3858279 was administered

GSK3858279 360 mg; GSK3858279 60 mg

Placebo DRUG

Placebo was administered

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (81)

GSK Investigational Site

Anniston, Alabama, 36207, United States

Location

GSK Investigational Site

Surprise, Arizona, 85378, United States

Location

GSK Investigational Site

Cerritos, California, 90703, United States

Location

GSK Investigational Site

Lomita, California, 90717, United States

Location

GSK Investigational Site

Largo, Florida, 33777, United States

Location

GSK Investigational Site

Miami, Florida, 33135, United States

Location

GSK Investigational Site

Miami, Florida, 33175, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33401, United States

Location

GSK Investigational Site

Decatur, Georgia, 30030, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Waltham, Massachusetts, 02451, United States

Location

GSK Investigational Site

Williamsville, New York, 14221, United States

Location

GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Lancaster, South Carolina, 29720, United States

Location

GSK Investigational Site

Cypress, Texas, 77429, United States

Location

GSK Investigational Site

DeSoto, Texas, 75154, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

McAllen, Texas, 78501, United States

Location

GSK Investigational Site

Bellevue, Washington, 98007, United States

Location

GSK Investigational Site

New Westminster, British Columbia, V3L 3W4, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Y 3W2, Canada

Location

GSK Investigational Site

Winnipeg, Manitoba, R3C 0N2, Canada

Location

GSK Investigational Site

Toronto, Ontario, L6S 0C6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2C4, Canada

Location

GSK Investigational Site

Beijing, 100032, China

Location

GSK Investigational Site

Guangzhou, 510000, China

Location

GSK Investigational Site

Harbin, 150001, China

Location

GSK Investigational Site

Luoyang, 471003, China

Location

GSK Investigational Site

Shanghai, 200032, China

Location

GSK Investigational Site

Wuhan, 430030, China

Location

GSK Investigational Site

Yueyang, 414000, China

Location

GSK Investigational Site

Corbeil-Essonnes, 91100, France

Location

GSK Investigational Site

Mulhouse, 68100, France

Location

GSK Investigational Site

Bad Homburg, 61348, Germany

Location

GSK Investigational Site

Mainz, 55128, Germany

Location

GSK Investigational Site

Münster, 48145, Germany

Location

GSK Investigational Site

Wallerfing, 94574, Germany

Location

GSK Investigational Site

Chiba, 260-0804, Japan

Location

GSK Investigational Site

Fukuoka, 807-8556, Japan

Location

GSK Investigational Site

Gunma, 370-3573, Japan

Location

GSK Investigational Site

Hokkaido, 060-0061, Japan

Location

GSK Investigational Site

Ibaraki, 300-0028, Japan

Location

GSK Investigational Site

Kanagawa, 211-8533, Japan

Location

GSK Investigational Site

Osaka, 565-0853, Japan

Location

GSK Investigational Site

Tochigi, 321-0204, Japan

Location

GSK Investigational Site

Tochigi, 321-0974, Japan

Location

GSK Investigational Site

Tochigi, 322-8550, Japan

Location

GSK Investigational Site

Tokyo, 103-0027, Japan

Location

GSK Investigational Site

Tokyo, 104-0031, Japan

Location

GSK Investigational Site

Tokyo, 143-0015, Japan

Location

GSK Investigational Site

Tokyo, 160-0008, Japan

Location

GSK Investigational Site

Częstochowa, 42-217, Poland

Location

GSK Investigational Site

Gdynia, 81-338, Poland

Location

GSK Investigational Site

Katowice, 40-081, Poland

Location

GSK Investigational Site

Katowice, 40-282, Poland

Location

GSK Investigational Site

Katowice, 40-648, Poland

Location

GSK Investigational Site

Katowice, 40-749, Poland

Location

GSK Investigational Site

Skorzewo, 60-185, Poland

Location

GSK Investigational Site

Sochaczew, 96-500, Poland

Location

GSK Investigational Site

Warsaw, 02-117, Poland

Location

GSK Investigational Site

Cape Town, 7530, South Africa

Location

GSK Investigational Site

Johannesburg, 2196, South Africa

Location

GSK Investigational Site

KwaDukuza, 4450, South Africa

Location

GSK Investigational Site

Pretoria, 0184, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

Location

GSK Investigational Site

Bucheon-si, 422711, South Korea

Location

GSK Investigational Site

Daejeon, 35233, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 136-705, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Seoul, South Korea

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Barcelona, 08023, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07120, Spain

Location

GSK Investigational Site

San SebastiAn de Los Rey, 28702, Spain

Location

GSK Investigational Site

Torrevieja Alicante, 3186, Spain

Location

GSK Investigational Site

Cannock, WS11 0BN, United Kingdom

Location

GSK Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

GSK Investigational Site

Teesside, TS17 6EW, United Kingdom

Location

GSK Investigational Site

West Yorkshire, LS10 1DU, United Kingdom

Location

MeSH Terms

Conditions

Pain; Diabetes Mellitus; Neuralgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

8664357343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Click here to enter text.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: September 20, 2023
• Primary Completion: October 14, 2024
• Study Completion: February 17, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (19); GB (4); CN (7); CA (5); DE (4); ZA (5); KR (6); ES (6); PL (9); JP (14)