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Follow on Google News | Paid Lupus Clinical Trial Now Enrolling at Achieve Clinical Research Near Birmingham, AlabamaAchieve is conducting a phase II, placebo-controlled, multi dose, 24-week clinical study to evaluate the efficacy and safety of a new autoimmune medication in participants living with systemic lupus erythematosus (SLE).
By: Achieve Clinical Research STUDY DESIGN This is a Phase IIb, multicenter, double-blind, placebo controlled (DBPC) parallel-arm research study in which participants are planned to be randomized in a ratio of 1:1:1 to receive placebo, or 75 mg or 150 mg of the experimental lupus drug, administered via weekly subcutaneous (SC) injections for 24 weeks. The trial is composed of a screening period, a DBPC treatment period, and a safety follow-up (FU) period. The trial will be conducted on an outpatient basis and treatment duration will be 24 weeks. A long-term extension (LTE) trial will be offered to completers of the 24-week treatment period as part of a separate protocol. BACKGROUND & RATIONALE This experimental lupus medication is a novel immunomodulator with B-cell targeting properties that is being developed for the treatment of SLE (http://www.achieveclinical.com/ This Phase IIb clinical trial is being conducted to evaluate the efficacy and safety of a new lupus drug compared to placebo in reducing the level of SLE disease activity in subjects with active lupus symptoms (http://www.achieveclinical.com/ PRIMARY OBJECTIVES The primary objective of this trial is to evaluate the efficacy of this experimental lupus medication compared to a placebo in reducing SLE disease activity in subjects treated with SoC therapy and to investigate the dose response relationship. INCLUSION CRITERIA Male or female of 18 years of age, who provide written informed consent at the screening visit. Diagnosis of SLE (http://www.achieveclinical.com/ Disease duration of at least 6 months from the time of diagnosis (when the subject met at least 4 of the ACR criteria) at the screening visit. SLEDAI-2K score 6 at screening visit. Positive test results for ANA (human epithelial cell [Hep]-2 ANA 1:80) and/or anti-dsDNA antibody (30 IU/mL) at screening visit. Women of childbearing potential must use highly effective methods of contraception to prevent pregnancy for 4 weeks before randomization and must agree to continue to practice adequate contraception for 60 days after the last dose of the study period. For the purposes of this trial, women of childbearing potential are defined as: All female subjects after puberty unless they are postmenopausal (defined by continuous amenorrhea) for at least 2 years or are surgically sterile. Highly effective contraception is defined as use of 2 barrier methods (e.g., female diaphragm and male condoms), 1 barrier method with spermicide, an intrauterine device or hormonal contraceptives (e.g., implant or oral). Note that because mycophenolate affects the metabolism of hormonal contraceptives and may reduce their effectiveness, women receiving mycophenolate who are using hormonal contraceptives for birth control should employ an additional contraceptive method (e.g., barrier method). Women of childbearing potential must have a negative serum pregnancy test at screening visit and a negative urine pregnancy test at Day 1/randomization before dosing. History of vaccinations against S. pneumococcus and influenza virus (http://www.achieveclinical.com/ *Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama (http://www.achieveclinical.com/ End
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