Adults 18 to 70, any sex, with Lupus Erythematosus, Cutaneous. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Emergent Chemistry Results by Potential Clinical Importance (PCI) CriteriaPrimary· Day 14, Day 28 and follow-up (up to Day 56)
Blood samples were collected to analyze the clinical chemistry parameters; albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), calcium, glucose, potassium (Pot) and sodium. PCI ranges were albumin (low: \<30 grams per liter), calcium (low: \<2 millimoles per liter \[mmol/L\] and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), Pot (low: \<3 mmol/L and high: \>5.5 mmol/L), sodium (low: \<130 mmol/L and high: \>150 mmol/L), ALT (high: \>=2 times upper limit of normal \[ULN\] units per liter {U/L}), AST
Albumin, Day 14, To low, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Albumin, Day 14, To normal or no change, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
11
Albumin, Day 28, To low, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Albumin, Day 28, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
Albumin, Follow-up, To low, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Albumin, Follow-up, To normal or no change, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
11
ALP, Day 14, To normal or no change, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
11
ALP, Day 14, To high, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Number of Participants With Emergent Hematology Results by PCI CriteriaPrimary· Day 14, Day 28 and follow-up (up to Day 56)
PCI ranges were hematocrit \[Hct\] (high: \>0.54 proportion of red blood cell \[RBC\] in blood), hemoglobin \[Hb\] (high: \>180 grams per liter), RBC (low: \<4.2x10\^12 cells per liter and high: \>5.9x10\^12 cells per liter), lymphocytes \[Lympho\] (low: \<0.8x10\^9 cells per liter), monocytes \[Mono\] (low: \<0.14x10\^9 cells per liter and high: \>1.3x10\^9 cells per liter), neutrophils \[Neutro\] (low: \<1.5x10\^9 cells per liter), platelet count \[PC\] (low: \<100x10\^9 cells per liter and high: \>550x10\^9 cells per liter), eosinophils \[Eos\] (high: \>0.55x10\^9 cells per liter), basophil
Baso, Day 14, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
Baso, Day 14, To high, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Baso, Day 28, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
Baso, Day 28, To high, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Baso, Follow-up, To normal or no change, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
11
Baso, Follow-up, To high, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Eos, Day 14, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
Eos, Day 14, To high, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
Change From Baseline in Urine Potential of Hydrogen (pH)Primary· Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)
Urine samples were collected to monitor the pH. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower number indicates the more acidic urine. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were comb
Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.10
± 0.843
Day 28, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.35
± 0.669
Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.32
± 0.783
Change From Baseline in Urine Specific GravityPrimary· Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)
Urine samples were collected to monitor the specific gravity. Specific gravity is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participan
Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0.0007
± 0.00629
Day 28, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.0001
± 0.00626
Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0.0003
± 0.00746
Number of Participants With Emergent Vital Sign Results by PCI CriteriaPrimary· Day 14 and Day 28
Vital signs such as diastolic blood pressure (DBP), heart rate (HR) and systolic blood pressure (SBP) were measured in semi-supine position after 5 minutes rest for the participants. PCI ranges were SBP (lower: \<85 millimeters of mercury \[mmHg\] and upper: \>160 mmHg), DBP: (lower: \<45 mmHg and upper: \>100 mmHg) and HR (lower: \<40 beats per minute \[bpm\] and upper: \>110 bpm). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.
DBP, Day 14, To low, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
DBP, Day 14, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
DBP, Day 14, To high, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
DBP, Day 28, To low, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
DBP, Day 28, To normal or no change, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
11
DBP, Day 28, To high, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
HR, Day 14, To low, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
0
HR, Day 14, To normal or no change, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
10
Change From Baseline in Electrocardiogram (ECG); HRPrimary· Baseline (Day 1), Day 14 and follow-up (up to Day 56)
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.
HR, Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
1.633
± 8.3702
HR, Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.606
± 4.1280
Change From Baseline in ECG; PR Interval, QRS Duration, QT Interval and QTcFPrimary· Baseline (Day 1), Day 14 and follow-up (up to Day 56)
Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.
PR interval, Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.900
± 5.2306
PR interval, Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
3.424
± 11.4174
QRS duration, Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-0.967
± 3.4728
QRS duration, Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
1.061
± 3.5113
QT interval, Day 14, n=0,10
Group
Value
95% CI
Group B-Participants With Natural Lesions
-4.467
± 21.8955
QT interval, Follow-up, n=0,11
Group
Value
95% CI
Group B-Participants With Natural Lesions
4.455
± 17.5463
QTcF interval, Day 14, n=0,3
Group
Value
95% CI
Group B-Participants With Natural Lesions
-2.739
± 7.4559
QTcF interval, Follow-up, n=0,4
Group
Value
95% CI
Group B-Participants With Natural Lesions
4.532
± 10.0979
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· Up to Day 56
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function.
Any AEs
Group
Value
95% CI
Group B-Participants With Natural Lesions
8
Any SAEs
Group
Value
95% CI
Group B-Participants With Natural Lesions
1
Change From Baseline in Erythema, Scaling Hyperkeratosis, Edema/Infiltration, Dyspigmentation, Modified Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) Activity Score and Overall RCLASI Modified Score.Secondary· Baseline (Day 1), Day 14 and Day 28
The score ranges for different components were; erythema \[0 (absent) to 3 (dark red, purple/violaceous/crusted/hemorrhagic)\], scaling/hyperkeratosis \[0 (absent) to 2 (verrucous hyperkeratosis)\], edema/infiltration \[0 (absent) to 2 (palpable and visible)\] and dyspigmentation \[0 (absent) to 2 (hypo and hyper pigmentation)\]. For all components, 0 (better) and 3 (worse). Modified RCLASI activity score was derived by adding score for erythema, scaling hyperkeratosis and edema/infiltration. Modified change from Baseline ranged from -7 to 7, 0 (no change), minus (better) and positive (worse).
Erythema, Day 14, n=0,0,9,9
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.8
± 0.83
Group B-Participants With Natural Lesions; GSK2646264
-0.8
± 0.83
Erythema, Day 28, n=0,0,10,10
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.5
± 0.71
Group B-Participants With Natural Lesions; GSK2646264
-0.5
± 0.71
Scaling/Hyperkeratosis, Day 14, n=0,0,9,9
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
0.0
± 0.00
Group B-Participants With Natural Lesions; GSK2646264
0.0
± 0.00
Scaling/Hyperkeratosis, Day 28, n=0,0,10,10
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
0.0
± 0.00
Group B-Participants With Natural Lesions; GSK2646264
0.0
± 0.00
Edema/infiltration, Day 14, n=0,0,9,9
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.2
± 0.44
Group B-Participants With Natural Lesions; GSK2646264
-0.2
± 0.44
Edema/infiltration, Day 28, n=0,0,10,10
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.4
± 0.52
Group B-Participants With Natural Lesions; GSK2646264
-0.3
± 0.48
Dyspigmentation, Day 14, n=0,0,9,9
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.1
± 0.33
Group B-Participants With Natural Lesions; GSK2646264
-0.1
± 0.33
Dyspigmentation, Day 28, n=0,0,10,10
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-0.1
± 0.32
Group B-Participants With Natural Lesions; GSK2646264
-0.1
± 0.32
Maximum Observed Concentration (Cmax) of GSK2646264 in Participants With Cutaneous Lupus Erythematosus (CLE)Secondary· Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)
Blood samples were collected at designated timepoints and pharmacokinetic (PK) analysis was performed. Cmax was calculated by non-compartmental analysis using WinNonlin. PK Population comprised of all participants in the safety population for whom a PK sample was obtained and analyzed.
Group
Value
95% CI
Group B-Participants With Natural Lesions
0.8324
± 109.3
Time to Reach Maximum Observed Concentration (Tmax) of GSK2646264 in Participants With CLESecondary· Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)
Blood samples were collected at designated timepoints and PK analysis was performed. Tmax was calculated by non-compartmental analysis using WinNonlin.
Group
Value
95% CI
Group B-Participants With Natural Lesions
311.467
4.68 – 651.92
Mean Fold Change in Messenger Ribonucleic Acid (mRNA) Expression of Interferon (IFN) Signatures in Skin BiopsiesSecondary· Baseline (Day -5 to -3) and Day 28
Microarray mRNA data was collected from the skin biopsy in both GSK2646264 and placebo treated lesions on Day -5 to -3 visit (Baseline) and Day 28. Fold change represents the change at Day 28 relative to Baseline for each treatment group. Analysis was conducted using mixed model with participant as a random effect and treatment as a fixed effect where treatment is set to "not applicable" at Baseline. Mean fold change and 95% confidence interval is presented for different genes and probesets. IFI16 indicated interferon, gamma-inducible protein 16, IFI44 indicated interferon-induced protein 44,
Chemokine (C-X-C motif)Ligand10, 204533_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.173
-1.899 – 2.610
Group B-Participants With Natural Lesions; GSK2646264
-1.464
-3.259 – 1.521
IFI16, 206332_s_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-1.001
-1.286 – 1.283
Group B-Participants With Natural Lesions; GSK2646264
-1.064
-1.367 – 1.207
IFI16, 208965_s_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.055
-1.219 – 1.356
Group B-Participants With Natural Lesions; GSK2646264
-1.164
-1.496 – 1.105
IFI16, 208966_x_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
-1.044
-1.328 – 1.219
Group B-Participants With Natural Lesions; GSK2646264
-1.096
-1.394 – 1.161
IFI44, 214059_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.018
-1.429 – 1.481
Group B-Participants With Natural Lesions; GSK2646264
-1.029
-1.497 – 1.413
IFI44, 214453_s_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.021
-1.541 – 1.606
Group B-Participants With Natural Lesions; GSK2646264
-1.270
-1.998 – 1.239
IFI44-like, 204439_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.043
-1.602 – 1.744
Group B-Participants With Natural Lesions; GSK2646264
-1.122
-1.875 – 1.491
IFIH1, 1555464_at, Day 28
Group
Value
95% CI
Group B-Participants With Natural Lesions; Placebo
1.037
-1.081 – 1.162
Group B-Participants With Natural Lesions; GSK2646264
-1.074
-1.204 – 1.043
Adverse events — posted to ClinicalTrials.gov
Time frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment up to Day 56.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group A-Participants With Photoprovocation Lesions
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 8 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02927457.