A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Institutional Review Board, Hospital for Special Surgery

October 15, 2019

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, DSc, FACP

Co-Investigators

Kyriakos A. Kirou, MD, DSc, FACP
David R. Fernandez, MD, PhD
Mary Peng

Summary

The purpose of the study is to see if Ustekinumab is effective for treating adults and children with Systemic Lupus Erythematosus (SLE). The safety of Ustekinumab will also be studied.

Ustekinumab has been approved by the U.S. Food and Drug Administration (FDA) and Regulatory Authority in the European Economic Area (EEA), Eastern Europe, South America and Asia-Pacific region for the treatment of patients with other immune diseases, such as adult and adolescent chronic moderate to severe plaque psoriasis, adult active psoriatic arthritis, and adult moderate to severely active Crohn’s disease. It is sold as STELARA®. Ustekinumab is not approved for the treatment of SLE. Its use is experimental in this study. Ustekinumab was evaluated in subjects with SLE in a previous clinical study with the same dosing regimen that will be further evaluated in this study.

The study has a 52-week double-blind study treatment period (year 1) and an optional open-label Extension Period (year 2 and onwards).

The purpose of the Double-Blind study treatment period of this study is to compare the effects (both good and bad) of Ustekinumab to those of placebo. Placebo looks just like Ustekinumab and is given the same way but has no active drug in it. You will be expected to come to the clinic about 16 times over the course of the year. Approximately 500 subjects will randomly be assigned to receive either Ustekinumab or placebo in a 3:2 ratio. Subjects will maintain their standard-of-care background therapy during the course of the study.

The purpose of the Extension period is to collect more information for approximately 2 more years after the Double-Blind study treatment period about whether Ustekinumab is safe, has side effects, and works in people with SLE. During this part of the study, you will only come to the clinic at least 5 times during a period of 124 weeks (almost two and a half years from the start of the Extension period). During this trial period, all subjects will receive Ustekinumab.

Inclusion/Exclusion Criteria

Someone CAN potentially be eligible to participate if they meet the following:

1. Male or female between 16-75 years of age, inclusive
2. Are capable of providing written consent to participate in the study
3. Are diagnosed with Systemic Lupus Erythematosus (SLE)
4. Demonstrate active disease, which will be determined and evaluated by a qualifying physician
5. Must be receiving one or more of the following treatments for at least the last 6-12 weeks:
6. Oral glucocorticoids ≤ 20 mg prednisone or equivalent per day
7. Anti-malarials: ≤ 250 mg/day chloroquine, ≤ 400 mg/day hydroxychloroquine, and/or ≤ 100 mg/day quinacrine
8. Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, mycophenolate
9. Are willing to perform and comply with all study procedures, including attending clinic visits as scheduled
10. Agree to practice at least 1 approved method of contraception

Someone CANNOT participate in this study if they have the following:

1. Has active TB
2. Is pregnant, nursing, planning a pregnancy, or planning to father a child while enrolled in the study or within 4 months after receiving the last administration of study agent
3. Has used oral cyclophosphamide in the last 90 days or IV cyclophosphamide in the last 180 days
4. Treatment with Belimumab (Benlysta) within last 3 months or treatment with Rituximab within last 12 months
5. Has a transplanted organ (except for a corneal transplant performed at  least 3 months prior to entering the study)
6. Presence or history of malignancy within the last 5 years (exceptions include squamous and basal cell carcinomas of the skin that have been treated with no evidence of recurrence for at least the last 3 months and carcinoma in situ of the cervix that has been documented to be surgically cured)
7. Has ever received stem cell transplantation  

Contact Information

Mary Peng
Research Coordinator
pengm@hss.edu
212.774.2967