At a glance
ClinicalIndex Comparison Record- ✓Age 18-70 years at consent
- ✓Confirmed diagnosis of Lupus Erythematosus Tumidus (LET) (group A only) or subacute/chronic CLE
- ✓Normal thyroid function (TSH, free T4, free T3 within normal range)
- ✓Body weight ≥50 kg and BMI 19.9-35 kg/m²
- ✕ALT >2× upper limit of normal (ULN)
- ✕Bilirubin >1.5× ULN (except isolated bilirubin >1.5× ULN if direct bilirubin <35%)
- ✕Current or chronic liver disease or known hepatic/biliary abnormalities (except Gilbert's syndrome or asymptomatic gallstones)
- ✕QTcF >450 msec (or >480 msec with Bundle Branch Block)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind (Sponsor Unblinded) Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Repeat Dosing of GSK2646264 in Cutaneous Lupus Erythematosus Patients
In Brief
A Phase 1 clinical trial evaluating GSK2646264 1% and Placebo for Lupus Erythematosus, Cutaneous. Completed, enrolled 11 participants across 5 sites.
Detailed Summary
This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by photoprovocation (PV). Current study is two group study. In Group A, Patients with fewer than two active lesions will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that develop PV lesions at any time during this period, as determined by the local investigative team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin pharmacokinetic (PK) of study drug, for 28 days. In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by the investigators will be enrolled into group B and have one lesion treated with 1% GSK2646264 and 1 lesion with placebo. A completed patient will be defined as a subject who receives at least 25 days of study drug and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients will be followed for 28 days in Group A only or until complete resolution of induced PV lesions, as determined by the investigator.
Study Details
Timeline
Interventions
A cream for topical application with a concentration of 1% GSK2646264.
Subjects will receive matching Placebo topically.