Select Ongoing Trials Currently Enrolling Patients with Lupus

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. Oral Tofacitinib in Patients with Discoid Lupus Erythematosus and SLE

The objective of this open-label, single-group, early phase 1 clinical trial is to assess the safety and activity of using oral tofacitinib in the treatment of adult patients who have discoid lupus erythematosus with or without concurrent systemic lupus erythematosus (SLE). Patients aged 18 to 65 years with a diagnosis of discoid lupus erythematosus and, in ≥50%, a diagnosis of SLE, may be eligible for enrollment if other criteria are met. Eligible patients will receive tofacitinib citrate twice daily for the duration of the 6-month trial.

The primary outcome measure is a change in the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) from baseline to week 24. This study plans to enroll 12 patients at the Tufts Medical Center, Boston, MA. For more information, contact Nicole Dumont at 617-636-7462 or ndonovan1@tuftsmedicalcenter.org. The NLM Identifier is NCT03159936.

2. Ustekinumab in Patients with SLE

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to assess the safety and efficacy of using ustekin­umab for the treatment of patients with SLE. Patients aged 18 to 75 years with SLE diagnosed in accordance with Systemic Lupus International Collaborating Clinics (SLICC) classification criteria who have tested positive for autoantibodies in ≥1 examinations may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ustekinumab plus a concomitant medication or placebo followed by ustekinumab plus a concomitant medication.

The primary outcome measure is the percentage of patients with a composite SLE Responder Index response at week 24. The secondary outcome measures are changes in SLE Disease Activity Index 2000 (SLEDAI-2K) score from baseline to week 24, the percentage of patients with a British Isles Lupus Assessment Group–Based Combined Lupus Assessment (BICLA) response, and changes in Physician Global Assessment of Disease Activity. This study plans to enroll 100 patients at multiple locations across the United States or abroad. For more information, contact jnj.ct@sylogent.com. The NLM Identifier is NCT02349061.

3. Subcutaneous Milatuzumab for Lupus Control in Patients with SLE

This randomized, double-blind, phase 1/2 clinical trial will determine the safety and efficacy of using subcutaneous milatuzumab to control lupus in patients with SLE. Patients aged ≥18 years with SLE diagnosed in accordance with American College of Rheumatology (ACR) revised criteria who test positive for antinuclear antibodies at the time of trial entry may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive subcutaneous milatuzumab at 1 of 2 doses or placebo.

The primary outcome measures are the safety and efficacy of subcutaneously administered milatuzumab over a time frame of 2 years. This study expects to enroll 30 patients at the Cedars-Sinai Medical Center Wallace Rheumatic Study Center, West Hollywood, CA. For more information, contact Heather Horne at 973-605-8200 (ext. 173) or hhorne@immunomedics.com or Florence Figueras at 310-360-9197 or ffigueras@wallacemedical.com. The NLM Identifier is NCT01845740.

4. BIIB059 in Patients with SLE or Cutaneous Lupus Erythematosus

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to assess the safety and efficacy of using BIIB059 to reduce skin disease activity in patients with SLE or active cutaneous lupus erythematosus with or without systemic manifestations, and to evaluate the dose–response relationship in patients with SLE and skin manifestations. Patients aged 18 to 75 years with a CLASI activity score of ≥8 at the time of screening and randomization who do not have active lupus nephritis or moderate-to-severe or chronic kidney disease may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive BIIB059 or placebo.

The primary outcome measure is the change in CLASI activity score from baseline to week 12. The secondary outcome measures include changes in immunoglobulin levels and vaccine titers over time, the absorption rate of BIIB059, and the number of patients who have clinically significant laboratory assessment abnormalities. This study plans to enroll 290 patients at multiple locations across the United States or abroad. For more information, contact Biogen at clinicaltrials@biogen.com. The NLM Identifier is NCT02847598.

5. Tolerability and Safety of Tofacitinib in Patients with SLE

This randomized, parallel-assignment, phase 1 clinical trial will determine the safety and tolerability of using tofacitinib in the treatment of patients with SLE. Patients aged 18 to 100 years with SLE diagnosed in accordance with ACR 1997 revised criteria who have a SLEDAI-2K score of 2 to 14 at the time of screening may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive tofacitinib or placebo.

The primary outcome measure is the safety of tofacitinib over a time frame of 5 years. The secondary outcome measures are clinical response and an assessment of biologic effects. This study expects to enroll 38 patients at the National Institutes of Health Clinical Center, Bethesda, MD. For more information, contact Yenealem Temesgen-Oyelakin, RN, at 301-451-4990 or yenealem.temesgen-oyelakin@nih.gov. The NLM Identifier is NCT02535689.

6. Safety and Efficacy of 3 Doses of Dapirolizumab Pegol in Patients with SLE

The objective of this randomized, double-blind, placebo-controlled, phase 2 clinical trial is to assess the safety and efficacy of using 3 different doses of dapiro­lizumab pegol in the treatment of adult patients with moderately to severely active SLE who are receiving standard care drugs. Patients aged ≥18 years with moderate-to-severe SLE diagnosed in accordance with SLICC classification criteria, and who are receiving a standard-of-care drug for their disease may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive dapirolizu­mab pegol at 1 of 3 doses or placebo.

The primary outcome measure is the percentage of patients with a BICLA response across all 3 doses of dapirolizumab pegol at week 24. The secondary outcome measure is the percentage of patients with a BICLA response in individual dose groups at week 24. This study plans to enroll 160 patients at multiple locations across the United States or abroad. For more information, contact UCB Cares at 844-599-2273 or UCBCares@ucb.com. The NLM Identifier is NCT02804763.

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