None listed
Conditions
Interventions
Subjects will be randomized to 1 of 5 blinded treatment groups in a 1:1:1:1:1 ratio to receive subcutaneous injections of 75 mg ALX-0061 every 4 weeks, 150 mg ALX-0061 every 4 weeks, 150 mg ALX-0061 e
subjects in ALX-0061 Groups will also be administered 2 injections q2w with 1 or both syringes containing placebo, depending on the assigned treatment group.
ALX-0061 will be supplied as a sterile
Sponsors
Ablynx,
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Adult ≥ 18 and < 65 years.2.Diagnosis of SLE and fulfill 1997 ACR or 2012 SLICC classification criteria for at least 6 months prior to screening.3.Have moderate to severe active SLE, defined by a SLEDAI-2K score ≥ 6.4.Have at least one A or one B score on BILAG 2004 criteria for the mucocutaneous and/or musculoskeletal system.5. Have seropositive disease at screening for ANA ≥ 1:80 and/or anti-dsDNA (≥ 30 IU/mL).6.Subject at least must be on one or more of the following treatments for SLE:a.oral corticosteroids. b.antimalarials. c.immunosuppressants; either alone or in combination with corticosteroids and/or hydroxychloroquine.7. immunosuppressants, the last dose should have been received more than 4 weeks prior to baseline; leflunomide or hydroxychloroquine treatment-free period of at least 12 weeks.8.angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blocker, the dose should have been stable for 4 weeks prior to baseline. 9.Chest X-ray no evidence of malignancy, infection, or abnormalities suggestive of tuberculosis.10. Are considered eligible according to the following TB screening criteria:a.no history of latent or active. b.no signs or symptoms suggestive of active TB .c.Have had no recent close contact with a person with active TB. d.negative interferon gamma release assay.e.chest X-ray with no evidence of current active TB or old inactive TB. 11.Female subjects of childbearing potential (excluding postmenopausal women, sterilized, ovariectomized and hysterectomized women) must have a negative pregnancy test and must agree to use two generally accepted adequate contraceptive. Male subjects must use condoms for the duration of the study and for at least 3 months after last dosing.12. Capability to comprehend and willingness to sign an ICF.13.An understanding, ability and willingness to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1.A score on the revised BILAG-2004 other than in the mucocutaneous and/or musculoskeletal.2.ystemic inflammatory disease other than SLE.3.Infection treated with antibiotics, antivirals, or antifungals within 2 to 4 weeks prior to baseline.4.Active or recurrent viral infection 5.history of, or current, class III or IV congestive heart failure , as defined by NYHA; history of unstable angina pectoris, myocardial infarction, cerebrovascular accident, thromboembolic event.6.active lupus nephritis. 7. lupus-related central neurological problems or severe CNS disease. 8. drug-induced lupus.9. history of demyelinating diseases.10.diverticulitis or symptoms of acute diverticulitis. 11.malignancy or lymphoproliferative disease. 12.transplanted organ or received stem cell transplantation. 13.Major surgery.14. treatment with i.v. immunoglobulins, cyclophosphamide or tacrolimus within 12 months prior to baseline. 15.Have received i.v., intra-articular (i.a.), intramuscular (i.m.) or high dose oral corticosteroids during the 4 weeks prior to baseline.16.known hypersensitivity to the active product or any excipient of the study drug.17.Have received approved or investigational biological therapies within 6 months or 5 half-lives.18.Have received non-biological investigational therapies within 4 weeks or 5 half lives.19.Have received prior therapy blocking the IL-6 pathway or Janus kinase (JAK) inhibitors.20.Abnormality in screening laboratory test results. 21.Positive screening for hepatitis B, hepatitis C or HIV 22.presence of alcohol or drug abuse.23.Blood donation (> 500 mL) or a comparable blood loss within 3 months prior to baseline. 24.Planned donation of germ cells, blood, organs, bone marrow.25.planning to become pregnant during the study or within 3 months after last dosing.26. Pregnant woman or female subjects who are breastfeeding.27.anaphylactic reactions.28. live, attenuated vaccine within 3 months before.29.Subject is considered by the Investigator to be an unsuitable candidate for the study.
Countries
Argentina, Chile, Czech Republic, Germany, Hungary, Korea South, Mexico, Peru, Philippines, Poland, Portugal, Russian Federation, Serbia, Spain, Taiwan, Ukraine, United States
Contacts
Public ContactJuanita Aching
PPD Peru S.A.C.
Outcome results
None listed