Clinical Trials Logo
  1. Home
  2. Lupus Erythematosus, Cutaneous
  3. NCT02927457

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects

Lupus Erythematosus, Cutaneous Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02927457
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date January 13, 2017
Completion date June 12, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT02034344 - A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers Phase 0
Terminated NCT01559155 - Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
Completed NCT01702740 - A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus Phase 1
Withdrawn NCT00222183 - Cutaneous Lupus Erythematosus and Elidel N/A
Withdrawn NCT04707924 - Efficacy of Fractional Er:YAG Laser in Lupus Erythematosus Scars N/A
Recruiting NCT05879718 - A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. Phase 2
Completed NCT01352988 - Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus Phase 2
Enrolling by invitation NCT00420121 - European Society of Cutaneous Lupus Erythematosus (EUSCLE) N/A
Completed NCT01845740 - Phase Ib Study of SC Milatuzumab in SLE Phase 1
Completed NCT02656082 - Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus Phase 2
Terminated NCT02428309 - Autologous Polyclonal Tregs for Lupus Phase 1
Completed NCT04493541 - A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus Phase 1
Terminated NCT01407679 - Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus Phase 2
Completed NCT01923415 - A Non-drug Study Profiling Cutaneous Lupus Phase 0