A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

NCT05838742 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2099782022-502799-22-00
• Study Type: interventional
• Target: 314
• Locations: 13 countries
• Sites: 93

Brief Summary

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.

Conditions

Pain; Osteoarthritis, Knee

Keywords

Osteoarthritis; Musculoskeletal Diseases; 209978; GSK3858279; Efficacy; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weekly Average of Average Daily Knee Pain Intensity Using Numeric Rating Scale at Week 12

  Change from Baseline in knee pain due to Osteoarthritis were reported by weekly average of average daily pain numeric rating scale (NRS) at Week 12. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average daily knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the weekly average of average daily pain score was calculated using the mean value of available daily pain scores falling in the assessment window for each week. A negative change from baseline indicates an improvement in pain. Participants were asked to complete the pain NRS questionnaire at the same time in the evening each day. Baseline scores were assigned based on an average of 7 days prior to day 1 dosing visit. Posterior mean change from baseline, 95 percent (%) credible interval (CI) was derived using Bayesian mixed model repeated measures. The data presented are the posterior mean with 95% confidence interval refers to 95% credible interval.

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

Secondary Outcomes (10)

• Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score At Week 12

  Baseline (Day 1) and at Week 12

• Change From Baseline in WOMAC Physical Function Subscale Score at Week 12

  Baseline (Day 1) and at Week 12

• Change From Baseline in Patient Global Assessment Of Disease (PtGA) at Week 12

  Baseline (Day 1) and at Week 12

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

  Up to 31 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 (NCICTCAE)

  Up to 31 weeks

Study Arms (5)

GSK3858279 - 60 mg weekly

EXPERIMENTAL

Participants received GSK3858279 60 milligram (mg) SC injection once per week for 16 weeks.

Drug: GSK3858279

GSK3858279 - 240 mg every 2 weeks

EXPERIMENTAL

Participants received GSK3858279 240 mg SC injection every other week for 16 weeks. Placebo was given in the intervening week to maintain the blinding.

Drug: GSK3858279

GSK3858279 - 240 mg weekly

EXPERIMENTAL

Participants received GSK3858279 240 mg SC injection once per week for 16 weeks.

Drug: GSK3858279

GSK3858279 - 360 mg weekly

EXPERIMENTAL

Participants received GSK3858279 360 mg SC injection once per week for 16 weeks.

Drug: GSK3858279

Placebo

PLACEBO COMPARATOR

Participants received placebo subcutaneous (SC) injection once per week for 16 weeks

Drug: Placebo

Interventions

GSK3858279 DRUG

GSK3858279 will be administered.

GSK3858279 - 240 mg every 2 weeks; GSK3858279 - 240 mg weekly; GSK3858279 - 360 mg weekly; GSK3858279 - 60 mg weekly

Placebo DRUG

Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 40 to 80 years of age inclusive
• OA of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
• Kellgren and Lawrence (KL) score ≥ 2 on X-ray in the index knee
• An average of the average daily pain score of ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10)
• Body mass index (BMI) of \< 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.
• History or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis.
• History of significant trauma or surgery to a knee or hip within the last 6 months.
• Current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency.
• Current or previous active Mycobacterium tuberculosis
• History or evidence of clinically significant multiple or severe drug allergies
• History of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN).
• Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35 percent (%)
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• Evidence of renal insufficiency, indicated by estimated creatinine clearance \< 60 milliliter/ minute (mL/min)/1.73 square meter (m\^2) at screening.
• Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (93)

GSK Investigational Site

Cerritos, California, 90703, United States

Location

GSK Investigational Site

Huntington Beach, California, 92647, United States

Location

GSK Investigational Site

Santa Clara, California, 95054, United States

Location

GSK Investigational Site

Cooper City, Florida, 33024, United States

Location

GSK Investigational Site

Cutler Bay, Florida, 33189, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

Miami, Florida, 33185, United States

Location

GSK Investigational Site

Wichita, Kansas, 67207, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40213, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Henderson, Nevada, 89052, United States

Location

GSK Investigational Site

Williamsville, New York, 14221, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27410, United States

Location

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22911, United States

Location

GSK Investigational Site

Buenos Aires, C1128AAF, Argentina

Location

GSK Investigational Site

Buenos Aires-San Isidro, 1643, Argentina

Location

GSK Investigational Site

Ciudad Autonoma Buenos Aires, C1417, Argentina

Location

GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, 1118, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1046AAQ, Argentina

Location

GSK Investigational Site

Mar del Plata, B7600FYK, Argentina

Location

GSK Investigational Site

Botany, New South Wales, 2019, Australia

Location

GSK Investigational Site

Kotara, New South Wales, 2289, Australia

Location

GSK Investigational Site

Sydney, New South Wales, 2010, Australia

Location

GSK Investigational Site

Camberwell, Victoria, 3124, Australia

Location

GSK Investigational Site

Victoria, British Columbia, V8V 4A1, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Guelph, Ontario, N1H 1B1, Canada

Location

GSK Investigational Site

Sarnia, Ontario, N7T 4X3, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5T 2S8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

Location

GSK Investigational Site

Winchester, Ontario, K0C 2K0, Canada

Location

GSK Investigational Site

Joliette, Quebec, J6E 6A9, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1L 0H8, Canada

Location

GSK Investigational Site

Trois-Rivières, Quebec, G9A 3X2, Canada

Location

GSK Investigational Site

Beijing, 100083, China

Location

GSK Investigational Site

Beijing, 100730, China

Location

GSK Investigational Site

Changchun, 130021, China

Location

GSK Investigational Site

Chengdu, 610041, China

Location

GSK Investigational Site

Guangzhou, 510000, China

Location

GSK Investigational Site

Hohhot, 010017, China

Location

GSK Investigational Site

Nanjing, 210009, China

Location

GSK Investigational Site

Shanghai, 200011, China

Location

GSK Investigational Site

Shanghai, 200040, China

Location

GSK Investigational Site

Shanghai, 200065, China

Location

GSK Investigational Site

Shenyang, 110022, China

Location

GSK Investigational Site

Shijiazhuang, 050051, China

Location

GSK Investigational Site

Tianjin, 300192, China

Location

GSK Investigational Site

Zhuzhou, 412007, China

Location

GSK Investigational Site

Dax, 40107, France

Location

GSK Investigational Site

La Roche-sur-Yon, 85925, France

Location

GSK Investigational Site

La Rochelle, 17019, France

Location

GSK Investigational Site

Montpellier, 34000, France

Location

GSK Investigational Site

Paris, 75012, France

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Hamburg, 20095, Germany

Location

GSK Investigational Site

Hamburg, 22415, Germany

Location

GSK Investigational Site

Magdeburg, 39120, Germany

Location

GSK Investigational Site

Fukuoka, 834-0115, Japan

Location

GSK Investigational Site

Ibaraki, 300-1234, Japan

Location

GSK Investigational Site

Ibaraki, 300-1253, Japan

Location

GSK Investigational Site

Nagano, 390-8601, Japan

Location

GSK Investigational Site

Nagano, 395-8505, Japan

Location

GSK Investigational Site

Osaka, 543-0027, Japan

Location

GSK Investigational Site

Saitama, 330-0074, Japan

Location

GSK Investigational Site

Shimane, 693-8501, Japan

Location

GSK Investigational Site

Tokyo, 103-0027, Japan

Location

GSK Investigational Site

Tokyo, 104-0031, Japan

Location

GSK Investigational Site

Tokyo, 113-8431, Japan

Location

GSK Investigational Site

Chihuahua City, 31000, Mexico

Location

GSK Investigational Site

Guadalajara, 44650, Mexico

Location

GSK Investigational Site

Mexicali, 21200, Mexico

Location

GSK Investigational Site

Mérida, CP 97070, Mexico

Location

GSK Investigational Site

Torreón, 27000, Mexico

Location

GSK Investigational Site

Cape Town, 7130, South Africa

Location

GSK Investigational Site

Cape Town, 7405, South Africa

Location

GSK Investigational Site

Gauteng, 1619, South Africa

Location

GSK Investigational Site

Johannesburg, 2113, South Africa

Location

GSK Investigational Site

Stellenbosch, 7600, South Africa

Location

GSK Investigational Site

Seoul, 03080, South Korea

Location

GSK Investigational Site

Seoul, 06973, South Korea

Location

GSK Investigational Site

Seoul, 07441, South Korea

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Barcelona, 08430, Spain

Location

GSK Investigational Site

Barcelona, 08540, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Santander, 39008, Spain

Location

GSK Investigational Site

Santiago de Compostela, 15702, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Blackpool, FY2 0JH, United Kingdom

Location

GSK Investigational Site

Cannock, WS11 0BN, United Kingdom

Location

GSK Investigational Site

London, EN5 3DJ, United Kingdom

Location

GSK Investigational Site

Manchester, M13 9NQ, United Kingdom

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee; Osteoarthritis; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

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
• 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 13, 2023
• Primary Completion: August 12, 2024
• Study Completion: December 3, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

JP (11); AU (4); FR (5); ME (5); CN (14); ZA (5); AR (6); DE (4); ES (7); GB (4); CA (10); US (15); KR (3)