Last updated: 02/16/2024 10:33:11
A study to investigate the efficacy and safety of GSK3196165 in inflammatory hand osteoarthritis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-centre Phase IIa double-blind, placebo-controlled study to investigate the efficacy and safety of GSK3196165 in subjects with inflammatory hand osteoarthritis
Trial description: This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA).Approximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from baseline in 24-hour average hand pain intensity at Week 6
Timeframe: Baseline and Week 6
Secondary outcomes:
Change from baseline in 24-hour average and worst hand pain intensity at each visit
Timeframe: Baseline through follow-up (Day 155)
Proportion of subjects in each treatment group achieving a 30% or 50% reduction in 24-hour average or worst hand pain intensity at each visit
Timeframe: Baseline through follow-up (Day 155)
Change from baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS
Timeframe: Baseline through Day 85
Change in number of swollen and tender hand joints at each visit
Timeframe: Baseline through follow-up (Day 155)
Change from baseline in patient global assessment (PtGA) and physician global assessment (PhGA) of disease activity
Timeframe: Baseline through follow-up (Day 155)
Incidence of adverse events and serious adverse events, including infections and pulmonary events
Timeframe: Baseline through follow-up (Day 155)
Anti-GSK3196165 antibodies
Timeframe: Baseline through Day 85
Population pharmacokinetics - total body clearance from plasms
Timeframe: Day 1 through Day 43
Population pharmacokinetics - total volume distribution
Timeframe: Day 1 through Day 43
Population pharmacokinetics - absorption rate constant
Timeframe: Day 1 through Day 43
Interventions:
Drug: GSK3196165
Drug: Placebo
Enrollment:
44
Observational study model:
Not applicable
Primary completion date:
2017-29-11
Time perspective:
Not applicable
Clinical publications:
Georg Schett, Chris Bainbridge, Mario Berkowitz, Katherine Davy, Sofia Fernandes, Eduard Griep, Stephen Harrison, James Lloyd-Hughes, Alexandra Morgan-Roberts, Mark Layton, Nonna Anna Nowak, Jatin Patel, Jürgen Rech, Sarah Watts, Paul P. Tak. A Phase IIa, randomised study of the safety, pharmacokinetics, pharmacodynamics and clinical activity of the anti-GM-CSF antibody GSK3196165 in patients with hand osteoarthritis. Lancet Rheumatol. 2020;
DOI: 10.1016/S2665-9913(20)30171-5
Medical condition
Osteoarthritis
Product
Otilimab
Collaborators
Not applicable
Study date(s)
March 2016 to November 2017
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Age >=18 years at the time of signing informed consent.
- Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the past 3 months.
- Pregnant or lactating women.
- History of any clinically significant inflammatory disease other than inflammatory HOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies.
Inclusion and exclusion criteria
Inclusion criteria:
- Age >=18 years at the time of signing informed consent.
- Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the past 3 months.
- Active disease at screening and randomization with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints in the affected hand.
- Signs of inflammation such as synovitis in the MRI scan of the affected hand.
- Must have a subject’s self assessment of 24-hour average hand pain intensity at baseline of at least ‘5’ on an 11-point Numerical Rating Scale (NRS, 0-10).
- Weight >=45 kilogram (kg).
- Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria.
- Diffusing capacity of the lung for carbon monoxide (DLCO) >=70% predicted; forced expiratory volume in 1 second (FEV1) >=80% predicted.
- No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Exclusion criteria:
- Pregnant or lactating women.
- History of any clinically significant inflammatory disease other than inflammatory HOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies.
- Diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other inflammatory rheumatological or autoimmune disorders.
- Clinical suspicion of, or previous investigation for CPPD or pseudogout, or history of chondrocalcinosis.
- Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target HOA joint(s).
- History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
- Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.
- History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis [PAP]).
- Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.
- Significant unstable or uncontrolled acute or chronic disease which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
- A history of malignancy.
- Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
- Current/previous Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2 infection.
Trial location(s)
Location
GSK Investigational Site
Canterbury, Kent, United Kingdom, CT1 3NG
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
North Shields, United Kingdom, NE298NH
Status
Study Complete
Location
GSK Investigational Site
Rendsburg, Schleswig-Holstein, Germany, 24768
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2017-29-11
Actual study completion date
2017-29-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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