Systemic lupus erythematosus MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: BOS161721
Product Code: BOS161721
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not known
CAS Number: 2229685-51-0
Current Sponsor code: BOS161721
Other descriptive na
Sponsors
Boston Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women, ages 18 to 70 years, inclusive 2. Patients must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study 3. Patients must have SLE as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of antinuclear antibodies [ANA] or anti- double-stranded deoxyribonucleic acid [dsDNA] antibodies), either sequentially or simultaneously 4. At screening, patients must have at least 1 of the following: a. Elevated ANA = 1:80 via immunofluorescent assay at the central laboratory b. Positive anti-dsDNA or anti-Smith (Sm) above the normal level asdetermined by the central laboratory 5. At screening, the total SLEDAI-2K score must be = 8, including points from at least 1 of the following clinical components: a. Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0. 6. A clinical SLEDAI-2K score of = 6 at screening at Day 0. Clinical SLEDAI-2K score is defined as follows: a. Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, or vasculitis b. Excludes parameters which require central laboratory results: hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0. 7. Patients must have at least 1 qualifying A or 2Bs from the following manifestations of SLE, as defined by the BILAG criteria as modified for use in this study, which must be confirmed by the central data reviewer: a. BILAG A or B score in the mucocutaneous body system. If a BILAG B score is due to BILAG number 6, mild skin eruption, the CLASI activity score including erythema and scale/hypertrophy must be = 3 excluding points from mucosal ulcers and alopecia. b. BILAG A or B score in the musculoskeletal body system due to active polyarthritis as defined in the protocol Section 4.4 Note: Hips, shoulders, back, neck, and temporomandibular joints do not count towards the total number of joints with active synovitis. If only one "B" and no "A" score is present in the mucocutaneous body system or in the musculoskeletal body system due to arthritis, then at least 1 "B" must be present in at least 1 other body system for a total of 2 "B" BILAG body system scores. 8. Patients must be currently receiving at least 1 of the following: a. Administration for a minimum of 12 weeks, and a stable dose for at least 56 days (8 weeks prior to Day 0) of the following permitted steroid-sparing agents: i. Azathioprine (AZA), mycophenolate mofetil or mycophenolic acid, chloroquine, hydroxychloroquine, or methotrexate (MTX) b. If AZA, myocophenolate mofetil, mycophenolic acid, hydroxychloroquine, or MTX were discontinued prior to screening, the washout period must be = 12 weeks. c. Corticosteroids (prednisone or prednisone-equivalent) at a stable dose of up to 30 mg/day for at leas
Exclusion criteria
Exclusion criteria: 1. Drug-induced SLE, rather than "idiopathic" SLE 2. Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis [RA], multiple sclerosis [MS], systemic sclerosis, or vasculitis not related to SLE) a. RA-Lupus overlap (Rupus), and secondary Sjögren syndrome are allowed 3. Any major surgery within 6 weeks of study drug administration, (Day 0), or any elective surgery planned during the course of the study 4. Any history or risk for tuberculosis (TB) -please see the details in the protocol 5. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed 6. Severe proliferative lupus nephritis, (WHO Class III, IV), which requires or may require induction treatment with cytotoxic agents or high dose CS 7. Concomitant illness that, in the opinion of the investigator or the sponsor or their designee, is likely to require additional systemic glucocorticosteroid therapy during the study, (eg, asthma), is exclusionary a. However, treatment for asthma with inhalational CS therapy is allowed 8. Use or planned use of concomitant medication outside of standard of baseline treatment for SLE from Day -1 or for any time during the study 9. Active and clinically significant infection (bacterial, fungal, viral, or other) within 60 days prior to first dose of study drug. Clinically significant is defined as requiring systemic parenteral antibiotics or hospitalization 10. A history of opportunistic infection, or a history of recurrent or severe disseminated herpes zoster or disseminated herpes simplex within the last 3 years 11. Chronic viral hepatitis including hepatitis B (HBV) and hepatitis C (HCV) unless patient received curative treatment for HCV and has a documented negative viral load, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness 12. Cryptosporidium in the stool sample at screening 13. White blood cells (WBC) 3.0 g/day (3000 mg/day) at screening or equivalent level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or 339 mg/mmol) 19. Serum creatinine > 2.0 mg/dL at screening or creatinine clearance (CrCL) 2 × the upper limit of normal (ULN) at screening, unless explicitly related to lupus based on the investigator's judgment 21. Creatinine kinase (CK) > 3.0 × ULN at screening unless related to lupus myositis 22. Total bilirubin > 1.5 × ULN at screening (unless related to Gilbert's syndrome) 23. Any other laboratory test results that, in the opinion of the Investigator or the sponsor or sponsor's designee, might place a patient at unacceptable risk for participating in this study 24. History of allergic or anaphylactic reaction to any therapeutic or diagnostic mAb (eg, IgG protein) or molecules made of components of mAbs 25. History substance and/or alcohol abuse, or dependence within the past 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of Concept (POC) Phase 2 Primary Objective: To demonstrate a superior effect of BOS161721 at the chosen dose compared with placebo for response on the SRI-4.;Secondary Objective: POC Phase 2 Secondary Objectives: To demonstrate a superior effect of BOS161721 at the chosen dose compared with placebo for response on clinical indicators of SLE activity, in adult patients with moderately to severely active SLE on limited background standard of care treatment.;Primary end point(s): POC Phase 2 Primary (Efficacy) Endpoints: The proportion of patients with a SRI-4 response at Day 210.;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of POC primary endpoints are listed in the endpoint description above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): POC Phase 2 Secondary (Efficacy) Endpoints: • The proportion of patients with: - SRI-4 response at each visit - SRI-5 and SRI-6 response at each visit (Section 6.3.4.2) - a sustained reduction from baseline of oral corticosteroid (CS) (= 7.5 mg/day and 1 qualifying BILAG B) through Day 210 - PGA worsening - a BICLA response - a CLASI response - medication failures • Results and changes from baseline in: - CLASI - Total number of swollen joints, tender joints, and active joints (swelling and tenderness in the same joint) in the ACR-28 joint count - SLEDAI-2K - SLICC/ACR damage index • Time to medication failure • Group mean percent reduction in corticosteroid administration from baseline Day 0 dose through Day 210 in patients receiving = 7.5 mg/day prednisone equivalent at Day 0 • Duration of longest SRI-4 response • Time to first SRI-4 response • Time to first BILAG flare (= 1 new or recurrent BILAG A or > 1 new or recurrent BILAG B) relative to baseline through Day 210;Timepoint(s) of evaluation of this end point: Timepoints for evaluation of POC secondary endpoints are listed in the endpoint description above. | — |
Countries
Argentina, Bulgaria, Colombia, Georgia, Hungary, Mexico, Peru, Philippines, Poland, Romania, Ukraine, United States
Contacts
Public ContactKathleen V. Murphy
Boston Pharmaceuticals, Inc.
Outcome results
None listed