Phase 2
N=44
A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02683785 ↗Enrolled (actual)
44
Serious AEs
6.8%
Results posted
Dec 2018
Primary outcome: Primary: Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6 — -1.34; -1.70 Scores on scale — p=0.442
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK3196165 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6 |
-1.34; -1.70 | 0.442 |
| SECONDARY Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit |
-0.13; -0.59; -0.48; -0.86; -0.74; -1.24 | 0.046 sig |
| SECONDARY Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit |
0.01; -0.45; -0.42; -0.69; -0.63; -1.23 | 0.082 |
| SECONDARY Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit |
0; 9; 0; 18; 5; 23 | — |
| SECONDARY Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit |
0; 0; 0; 9; 0; 18 | — |
| SECONDARY Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit |
0; 9; 0; 18; 0; 23 | — |
| SECONDARY Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit |
0; 0; 0; 5; 0; 14 | — |
| SECONDARY Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit. |
0.8; -1.9; -1.8; -3.7; -3.5; -7.2 | 0.061 |
| SECONDARY Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit |
-0.3; -0.3; -1.6; -1.2; -1.6; -2.1 | 0.957 |
| SECONDARY Change From Baseline in Number of Tender Hand Joints at Each Visit |
-0.6; -1.8; -1.7; -2.1; -1.1; -3.0 | 0.463 |
| SECONDARY Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity |
-1.8; -1.5; -2.1; -2.6; -2.2; -3.4 | 0.586 |
| SECONDARY Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity |
-0.4; -0.6; -0.6; -1.3; -0.9; -1.8 | 0.651 |
| SECONDARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
11; 13; 1; 2 | — |
| SECONDARY Number of Participants With Infections |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Pulmonary Events |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-GSK3196165 Binding Antibodies |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Apparent Clearance After Subcutaneous Administration (CL/F) of GSK3196165 |
4.94 | — |
| SECONDARY Apparent Steady State Volume of Distribution After Subcutaneous Administration (Vss/F) of GSK3196165 |
36.5 | — |
| SECONDARY Absoption Rate Constant (Ka) of GSK3196165 |
0.205 | — |
| SECONDARY Serum Concentration of GSK3196165 by Visit |
2457.05; 1767.55; 2821.12; 1802.09; 800.96; 56.40 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02683785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.