Cutaneous Lupus Erythematosus Clinical Trial
Official title:
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
The primary objectives of the study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab, safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity. Stage 1 and Stage 2 of the study will have broadly identical study designs with the exception of sample size. Both Stages of the study will have a randomized, double-blind, placebo-controlled design, followed by an open-label treatment period. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01776190 -
Low-dose UVA1 Radiation in Cutaneous Lupus Patients
|
N/A | |
| Completed |
NCT00420173 -
Interdisciplinary Study Group of Lupus Erythematosus (ISGLE)
|
N/A | |
| Terminated |
NCT04809623 -
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)
|
Phase 1 | |
| Completed |
NCT01300208 -
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
|
Phase 2 | |
| Terminated |
NCT01470313 -
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
|
Phase 1 | |
| Completed |
NCT01146444 -
Sunscreens in Patients With Cutaneous Lupus Erythematosus(CLE)
|
N/A | |
| Completed |
NCT03134222 -
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
|
Phase 2 | |
| Completed |
NCT01629784 -
Effectiveness of a Knowledge-based Intervention for Patients With Cutaneous Lupus Erythematosus
|
N/A | |
| Completed |
NCT00470912 -
Sunscreen RV 2457C in Photoinduced CLE
|
Phase 3 | |
| Completed |
NCT01841619 -
IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
|
Phase 0 | |
| Completed |
NCT00523588 -
Treatment of Cutaneous Lupus Erythematosus (CLE) With the 595 nm Flashlamp Pulsed Dye Laser
|
Phase 2 | |
| Terminated |
NCT01498406 -
Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus
|
Phase 2 | |
| Completed |
NCT04647708 -
Study of M5049 in CLE and SLE Participants
|
Phase 1 | |
| Completed |
NCT03817424 -
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
|
Phase 1 | |
| Active, not recruiting |
NCT03260166 -
Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00317681 -
Efficacy of Topical Tacrolimus in Different Subtypes With Cutaneous Lupus Erythematosus (CLE)
|
Phase 2 | |
| Completed |
NCT04781816 -
Proof of Concept Study of SAR443122 in Patients With Cutaneous Lupus Erythematosus
|
Phase 2 |