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Rheumatology Practice Management October 2016 Vol 4 No 5 - Clinical Trials Tracker

The following clinical trials represent a selection of key studies that are currently recruiting patients with lupus for inclusion in investigations of new therapies and new regimens of existing treatments for individuals with the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help rheumatology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Use of Ustekinumab in Patients with Active Systemic Lupus Erythematosus

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to evaluate the efficacy of using ustekinumab in patients with active systemic lupus erythematosus (SLE). Patients from both sexes aged 18 to 75 years who have had a documented medical history of SLE for ≥3 months before their first dose of ustekinumab may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive approximately 6 mg/kg of intravenous (IV) ustekinumab at week 0 followed by subcutaneous (SC) ustekinumab 90 mg every 8 weeks until week 40, or IV placebo at week 0 followed by SC placebo at weeks 8 and 16. Starting at week 24, patients in the placebo group will receive SC ustekinumab every 8 weeks until week 40.

The primary outcome measure is the percentage of patients with a response to the composite SLE Responder Index (SRI) at week 24. Secondary outcome measures are changes in SLE Disease Activity Index (SLEDAI) 2000 scores and Physician Global Assessment of Disease Activity from baseline to week 24, and the percentage of patients with a response to the British Isles Lupus Assessment Group (BILAG)-based Combined Lupus Assessment (CLA) at week 24. This study plans to enroll 100 patients at multiple locations across the United States and abroad. For more information, contact JNJ.CT@sylogent.com. The NLM Identifier is NCT02349061.

2 Efficacy, Safety, and Tolerability of CC-220 in Patients with Systemic Lupus Erythematosus

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will assess whether CC-220 is effective in treating skin, joint, and serologic manifestations of SLE. Patients from both sexes aged ≥18 years who have an established diagnosis of SLE with a disease history of ≥6 months at baseline, and no known history of human immunodeficiency virus or acquired immunodeficiency syndrome may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive oral CC-220 or placebo.

The primary outcome measures are the type, frequency, severity, and association of adverse events to the study drug, and improvements in skin manifestations and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity scores. Secondary outcome measures include various pharmacokinetics of CC-220 (eg, maximum and minimum observed in plasma concentration), and changes in joint count scores. This study expects to enroll 140 patients at multiple locations across the United States. For more information, contact Michelle Kilcoyne at 732-652-6549 or mkilcoyne@celgene.com, or Michael Weiswasser at 732-652-6462 or mweiswasser@celgene.com. The NLM Identifier is NCT02185040.

3 Efficacy and Safety of BIIB059 in Patients with Systemic Lupus Erythematosus or Active Cutaneous Lupus Erythematosus

The purpose of this randomized, double-blind, parallel-assignment, phase 2 clinical trial is to evaluate the efficacy of BIIB059 in reducing skin disease activity in 2 subsets of patients: those with SLE, and those with active cutaneous lupus erythematosus with or without systemic manifestations. Dose–response relationship in patients with active SLE and skin manifestations will also be assessed. Patients from both sexes aged 18 to 75 years who have a CLASI activity score of ≥8 at the time of screening and randomization, and no history of chronic, recurrent, or recent serious infection may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive BIIB059 or placebo every 4 weeks.

The primary outcome measure is the percent change in CLASI activity score from baseline. Secondary outcome measures include a 50% improvement from baseline in CLASI activity scores, BIIB059 absorption rate, and the number of patients who have positive serum BIIB059 antibodies. This study plans to enroll 290 patients at multiple locations across the United States. For more information, contact clinicaltrials@biogen.com. The NLM Identifier is NCT02847598.

4 Mycophenolate Mofetil Withdrawal in Patients with Stable, Inactive Systemic Lupus Erythematosus

This randomized, parallel-assignment, open-label, phase 2 clinical trial will define the effect of withdrawal from mycophenolate mofetil on risk for clinically significant disease reactivation in patients with inactive SLE who have received long-term therapy with mycophenolate mofetil. Patients from both sexes aged 18 to 70 years who have a diagnosis of SLE in accordance with American College of Rheumatology (ACR) criteria, a Physician Global Assessment score of ≤1 at the time of screening, and who have been receiving a stable dose of mycophenolate mofetil (1000-3000 mg/day) for ≥12 weeks before randomization may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to either continue treatment with mycophenolate mofetil, or be tapered off the drug.

The primary outcome measure is the probability of patients in both treatment arms experiencing clinically significant disease reactivation. Secondary outcome measures include time to clinically significant disease reactivation, the probability of adding aggressive adjunctive therapy to mycophenolate mofetil because of a flare, and the amount of SLE-related grade 3 to 5 adverse events. This study expects to enroll 120 patients at multiple locations across the United States. For more information, contact Sheryl Delancy at 405-271-8001 ext 34400 or sheryl-delancy@omrf.org. The NLM Identifier is NCT01946880.

5 Efficacy and Safety of Dapirolizumab Pegol in Patients with Moderate-to-Severe Active Systemic Lupus Erythematosus

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to assess the efficacy and safety of 3 different doses of dapirolizumab pegol compared with placebo in adults with moderate-to-severe active SLE who are receiving standard-of-care medications. Patients from both sexes aged ≥18 years with clinically diagnosed SLE, moderate-to-severe SLE disease activity, and no clinically significant active or latent infections may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive 1 of 3 doses of dapirolizumab pegol, or placebo.

The primary outcome measure is the percentage of patients with BILAG 2004–based CLA responses to 3 unique doses of dapirolizumab pegol, and to placebo, at week 24. The secondary outcome measure is the percentage of patients in the individual dose groups with BILAG 2004–based CLA responses at week 24. This study plans to enroll 160 patients at multiple locations across the United States. For more information, contact UCB Cares at 887-822-9493. The NLM Identifier is NCT02804763.

6 Use of Brentuximab Vedotin in Adults with Active Systemic Lupus Erythematosus

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will examine the safety and tolerability of brentuximab vedotin use in adults with active SLE. Patients from both sexes aged ≥18 years with SLE diagnosed ≥6 months before screening who have no recent, serious, or ongoing infections, and whose disease failed to respond to a treatment trial of ≥3 months may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive brentuximab vedotin, which is an antibody drug conjugate, or placebo.

The primary outcome measures are the number and percentage of patients who experience adverse events. Secondary outcome measures include the proportion of patients who achieve a SLEDAI clinical response (ie, a ≥4 point improvement from baseline), the occurrence of antitherapeutic antibodies, and the maximum observed concentration of brentuximab vedotin and metabolites total antibody, and monomethyl auristatin E. This study expects to enroll 40 patients at multiple locations across the United States. For more information, contact Terri Lowe at 866-333-7436 or clinicaltrials@seagen.com. The NLM Identifier is NCT02533570.

7 Efficacy and Safety of Belimumab in Adults with Active Lupus Nephritis

The purpose of this randomized, double-blind, placebo-controlled, phase 3 clinical trial is to assess the efficacy, safety, and tolerability of treating adult patients with active lupus nephritis with belimumab. Patients from both sexes aged ≥18 years who have a diagnosis of SLE in accordance with ACR criteria, biopsy-confirmed active lupus nephritis, and have not received treatment with belimumab in the past year may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard therapy in combination with either placebo or IV belimumab 10 mg/kg.

The primary outcome measure is the number of patients who have a renal response at week 104. Secondary outcome measures are the number of patients who experience adverse events, and the number of patients who achieve a complete renal response at weeks 52 and 104. This study plans to enroll 464 patients at multiple locations across the United States and abroad. For more information, contact the US GlaxoSmithKline Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com. The NLM Identifier is NCT01639339.

8 Effect of XmAb5871 on Systemic Lupus Erythematosus Disease Activity

This randomized, double-blind, placebo-controlled, phase 2 clinical trial will determine the ability of XmAb5871 in maintaining SLE disease activity improvement achieved with a short course of disease-suppressing steroid therapy. Patients from both sexes aged 18 to 65 years who have a diagnosis of SLE in accordance with ACR criteria, and no history of clinically unstable or uncontrolled disorders, conditions, or diseases (other than SLE) may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive IV XmAb5871 administered for up to 12 infusions, or a matching dose of placebo.

The primary outcome measure is the percentage of patients who do not experience a loss in SLE disease activity improvement on day 169. Secondary outcome measures are the number of patients who experience adverse events (including treatment-emergent and serious events), and the time to loss of SLE disease activity improvement achieved via a short, intramuscular steroid therapy injection. This study expects to enroll 90 patients at multiple locations across the United States. For more information, contact Debra Zack, MD, at 858-480-3893 or dzack@xencor.com, or Steve DeMattos, BS, at 858-480-3892 or sdemattos@xencor.com. The NLM Identifier is NCT02725515.

9 Safety and Efficacy of Baricitinib Use in Patients with Systemic Lupus Erythematosus

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to examine the efficacy and safety of using baricitinib to treat patients with SLE. Patients from both sexes aged ≥18 years who were diagnosed with SLE ≥24 weeks before screening, have SLEDAI 2000 scores of ≥4 based on clinical symptoms, and do not have active severe lupus nephritis may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive oral baricitinib or placebo once a day for 24 weeks.

The primary outcome measure is the proportion of patients who achieve arthritis or rash remission according to SLEDAI 2000. Secondary outcome measures are the proportion of patients who achieve SRI-4 responses, changes from baseline in SLEDAI 2000 scores and Patient’s Global Assessment of Disease Activity, as well as the pharmacokinetics of baricitinib. This study plans to enroll 300 patients at multiple locations across the United States and abroad. For more information, contact 877-285-4559 or 317-615-4559. The NLM Identifier is NCT02708095.

10 Efficacy and Safety of 2 Doses of Anifrolumab in Adults with Active Proliferative Lupus Nephritis

This randomized, multicenter, double-blind, phase 2 clinical trial will assess the efficacy and safety of treating adult patients who have active proliferative lupus nephritis with 2 doses of anifrolumab. Patients from both sexes aged 18 to 70 years who fulfill ≥4 specific criteria for SLE according to ACR, and have no known intolerance to receiving ≤1 gm/day of mycophenolate mofetil may be eligible for enrollment if other criteria are met. Eligible patients will have placebo or a high or low dose of IV anifrolumab added to their standard therapy of mycophenolate mofetil and corticosteroids.

The primary outcome measure is the relative change from baseline to week 52 in 24-hour urine protein to creatinine ratio. Secondary outcome measures include the difference in the proportion of patients who achieve complete renal responses and alternative complete renal responses, as well as the safety and tolerability of the treatment regimen. This study expects to enroll 150 patients at multiple locations across the United States and abroad. For more information, contact the AstraZeneca Clinical Study Information Center at 877-240-9479 or information.center@astrazeneca.com. The NLM Identifier is NCT02547922.

11 Adding Belimumab to Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus

The purpose of this randomized, multicenter, placebo-controlled, phase 2 clinical trial is to examine the safety, pharmacokinetics, and efficacy of using belimumab to treat pediatric patients who have active SLE. Patients from both sexes aged 5 to 17 years who have a diagnosis of SLE in accordance with ACR criteria, test positively for antinuclear antibodies, and do not have severe lupus kidney disease may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive a monthly dose of IV belimumab 10 mg/kg or placebo.

The primary outcome measures are SLE response index scores at week 52. Secondary outcome measures include the proportion of patients with sustained SLE response index reactions, and the number and percent of patients who experience adverse events. This study plans to enroll 100 patients at multiple locations across the United States and abroad. For more information, contact the US GlaxoSmithKline Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com. The NLM Identifier is NCT01649765.

12 Using MSC2364447C to Treat Patients with Systemic Lupus Erythematosus

This randomized, double-blind, parallel-assignment, phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics, and biologic effect of administering MSC2364447C for 4 weeks in patients with SLE. Patients from both sexes aged 18 to 65 years with SLE diagnosed ≥6 months before screening, and according to ACR criteria, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive MSC2364447C at 25-mg or 75-mg doses orally once daily, or a matching dose of placebo.

The primary outcome measures are the number of patients with clinically significant laboratory abnormalities, abnormal vital signs, and abnormal electrocardiograms, and the amount of patients who experience treatment-emergent adverse events, including having them graded according to severity. This study expects to enroll 24 patients at multiple locations across the United States and abroad. For more information, contact US Medical Information at 888-275-7376. The NLM Identifier is NCT02537028.

13 Efficacy of RSLV-132 in Patients with Systemic Lupus Erythematosus

The objective of this randomized, double-blind, parallel-assignment, phase 2 clinical trial is to evaluate the impact that 13 biweekly infusions of RSLV-132 have on cutaneous manifestations in patients with SLE. Patients from both sexes aged 18 to 70 years who have a CLASI score of ≥10 at baseline, and are positive for ≥1 RNA antibodies may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive IV RSLV-132 10 mg/kg, or placebo.

The primary outcome measure is the proportion of patients treated with RSLV-132 who had CLASI improvement compared with those who received placebo. Secondary outcome measures are the proportion of patients treated with RSLV-132 who experience steroid reduction and improvement in the Functional Assessment of Chronic Illness Therapy-Fatigue scale compared with those who received placebo. This study plans to enroll 50 patients at multiple locations across the United States. For more information, contact James Posada, PhD, at 208-727-7010 or jp@resolvebio.com. The NLM Identifier is NCT02660944.

14 Efficacy and Safety of Adding IPP201101 to Standard Therapy in Patients with Systemic Lupus Erythematosus

This randomized, double-blind, parallel-assignment, phase 3 clinical trial will assess the efficacy and safety of administering subcutaneous IPP201101 in patients with active SLE. Patients from both sexes aged 18 to 70 years who have a diagnosis of SLE in accordance with ACR criteria, test positively for antinuclear antibodies at screening, and do not have New York Heart Association class 3 or 4 congestive heart failure may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard therapy plus either SC PP201101 or placebo.

The primary outcome measure is the assessment of SRI responses at week 52. Secondary outcome measures include SRI responses at each study visit, reductions in SLEDAI 2000 scores by ≥4 points, and the incidence of disease flares. This study expects to enroll 200 patients at multiple locations across the United States and abroad. For more information, contact Daniel Wallace at 310-360-9197 or danielwallace@gmail.com. The NLM Identifier is NCT02504645.

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Last modified: November 1, 2016
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