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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 18 January 2021
Main ID:  EUCTR2018-000305-23-BG
Date of registration: 12/11/2018
Prospective Registration: Yes
Primary sponsor: Boston Pharmaceuticals, Inc.
Public title: A Phase 1b/2 Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients
Scientific title: A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
Date of first enrolment: 20/03/2019
Target sample size: 156
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000305-23
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Bulgaria Colombia Georgia Hungary Mexico Peru Philippines
Poland Romania Ukraine United States
Contacts
Name: Kathleen V. Murphy    
Address:  55 Cambridge Parkway, Suite 400 02142 Cambridge, MA United States
Telephone: +16178260287
Email: kat@bostonpharmaceuticals.com
Affiliation:  Boston Pharmaceuticals, Inc.
Name: Kathleen V. Murphy    
Address:  55 Cambridge Parkway, Suite 400 02142 Cambridge, MA United States
Telephone: +16178260287
Email: kat@bostonpharmaceuticals.com
Affiliation:  Boston Pharmaceuticals, Inc.
Key inclusion & exclusion 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:
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) < 1,200/mm3 (1.2 × 109/L) at screening
14. Absolute neutrophil count (ANC) < 500/mm3 at screening
15. CD4+ count < 150/µL at screening
16. Platelets < 50,000/mm3 (50 × 109/L) or < 35,000/ mm3 (35 ×
109/L) if related to SLE, at screening
17. Hemoglobin < 8 g/dL or < 7 g/dL at screening if related to SLE
18. Proteinuria > 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) < 40 ml/minute based on Cockcroft-Gault calculation
20. Serum alanine aminotransferase (ALT) and/or serum aspartate
aminotransferase (AST) > 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Intervention(s)

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 name: IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50 -
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
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.
Primary end point(s): POC Phase 2 Primary (Efficacy) Endpoints:

The proportion of patients with a SRI-4 response at Day 210.
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.
Timepoint(s) of evaluation of this end point: Timepoints for evaluation of POC primary endpoints are listed in the endpoint description above.
Secondary Outcome(s)
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 < Day 0 dose) between Day 150 and Day 210
- new or recurrent BILAG flares (= 1 qualifying BILAG A or > 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.
Secondary ID(s)
BOS161721-02
NCT03371251
Source(s) of Monetary Support
Boston Pharmaceuticals, Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 20/03/2019
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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