A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247)

A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247) - study 201247

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49656

Enrollment

Registered

2018-07-09

Start date

2019-01-29

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic sclerosis

Interventions

Treatment with GSK2330811 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Males and females *18 years of age. * Documented systemic sclerosis with cutaneous involvement and a disease duration of *60 months and an mRSS *10 and *35 at screening. * Active disease. See protocol section 6.1, item 5 for details. * An area of uninvolved or mildly thickened skin that would allow subcutaneous injection on abdomen, thigh or upper arm and on the fore arm for skin biopsies. See protocol section 6.1, item 6-7 for details. * Treatment with mycophenolate mofetil (*3,000 mg/day) or mycophenolate sodium (*1,440 mg/day), oral corticosteroids (*10 mg/day of prednisone or equivalent), phosphodiesterase 5 inhibitors and endothelin receptor antagonists is permitted. See protocol section 6.1, item 8-11 for details. * Female participants of childbearing potential: see protocol section 6.1, item 12b for details.

Exclusion criteria

Exclusion criteria: * Limited cutaneous SSc subset. * Rheumatic autoimmune disease other than dcSSc. See protocol section 6.2, item 2 for details. * FVC *50% of predicted, or a diffusing capacity of the lung for carbon dioxide (DLCO) (corrected for hemoglobin) *40% of predicted. * Pulmonary arterial hypertension, clinically significant inflammatory myositis. * SSc renal crisis within 6 months of first dosing of study medication. * Significant co-morbidities. See protocol section 6.2, item 7-10 for details. * Active infection or history of infections within 6 months of first dosing. See protocol section 6.2, item 11 for details. * Prior or concomitant therapy as mentioned in protocol section 6.2, item 17-27.

Design outcomes

Primary

Measure	Time frame
Adverse events. Effects on laboratory, ECG parameters and vital signs (blood pressure, heart rate, temperature).	—

Secondary

Measure	Time frame
Plasma concentrations of GSK2330811 and derived PK parameters. Serum levels of total and free OSM. Incidence of anti-GSK2330811 antibodies. Additional exploratory endpoints are included to explore pharmacology and effect on selected clinical endpoints and biomarkers of fibrosis, inflammation and vasculopathy in blood and skin.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)