This study has been transitioned to CTIS with ID 2023-505696-74-00 check the CTIS register for the current data. The primary objective of this study is to demonstrate efficacy of BIIB059compared with placebo in participants with active systemic…
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of Participants Who Achieved a Systemic Lupus
Erythematosus Responder Index of 4 (SRI-4) Response at Week 52
Secondary outcome
1. Percentage of Participants Who Achieved an SRI-4 Response at Week
2. Percentage of Participants With at Least 4 Joints (Both Swollen and Tender)
at Baseline Who Achieved a Joint-50 Response at Week 52.
3. Percentage of Participants with OCS >=10 milligrams per day (mg/day) at
Baseline Who Have OCS Reduction to <=7.5 mg/day at Week 40, Which Is Sustained
Through Week 52 with No Disease Worsening from Week 40 to Week 52
4. Percentage of Participants with a CLASI-A Score >=10 at Baseline Who Achieved
a 50% Improvement from Baseline in Cutaneous Lupus Erythematosus Disease Area
and Severity Index Activity Score (CLASI- 50) Response at Week 16
5. Annualized Flare Rate Through Week 52
6. Change from Baseline in Physician's Global Assessment (PGA) - Visual Analog
Scale (VAS) Score by Visit
7. Percentage of Participants Who Achieved a British Isles Lupus Activity Group
(BILAG)-Based Combined Lupus Assessment (BICLA) Response by Visit
8. Time to Onset of SRI-4 Response Sustained Through Week 52
9. Percentage of Participants Who Achieved SRI-4, -5, or -6 Response by Visit
10. Percentage of Participants with Joint-50 Response by Visit
11. Percentage of Participants with Baseline CLASI-A Score >=10 Who Achieved a
CLASI- 20, -50, -70, or -90 Response by Visit
12. Percentage of Participants with Baseline CLASI-A Score >=10 Who Achieved a
CLASI-A Score of <=1 by Vis
13. Time to First British Isles Lupus Activity Group-2004 (BILAG-2004) Severe
Flare by Visit
14. Time to first severe SFI flare during the double blind, placebo- controlled
treatment period, where severe flare is defined using the SFI definition
15. Percentage of time spent in LLDAS.
16. Proportion of participants with sustained LLDAS as defined by the number of
participants with >= 3, >= 5, and >= 7 consecutive visits in LLDAS up to and
including Week 52.
17. Proportion of participants who achieved LLDAS at Week 52.15. Percentage of
Participants with Baseline OCS >=10 mg/day Who Achieved <=7.5 mg/day at Week 52
16. Change from Baseline in Lupus-Specific Health-Related Quality-of- Life
Questionnaire (LupusQoL) Score
17. Change from Baseline in Short Form Health Survey-36 (SF-36) Score
18. Change from Baseline in Functional Assessment of Chronic Illness Therapy-
Fatigue (FACIT-Fatigue) Score
19. Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score
20. Change from Baseline in Work Productivity and Activity Impairment (WPAI):
Lupus Score
21. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and
Serious Adverse Events (SAEs)
22. Number of Participants with Antibodies to BIIB059
Background summary
Systemic Lupus Erythematosus (SLE) is an autoimmune disease that affects
multiple organ systems and is unpredictable in disease severity, with periods
of worsening illness or flares, alternating with periods of low disease
activity and remission. The presentation of lupus may vary including but not
limited to, rash, arthritis, anemia, thrombocytopenia, serositis, nephritis,
seizures, and psychosis
This application concerns a Phase 3 study in which it is proposed to
demonstrate efficacy of BIIB059 compared with placebo in adult participants
with active SLE, who are receiving background nonbiologic standard of care
(SOC) therapy in reducing disease activity*
Study objective
This study has been transitioned to CTIS with ID 2023-505696-74-00 check the CTIS register for the current data.
The primary objective of this study is to demonstrate efficacy of BIIB059
compared with placebo in participants with active systemic lupus
erythematosus (SLE), who are receiving background lupus standard of
care (SOC) therapy in reducing disease activity.
Study design
This is a multicenter, randomized, double-blind,
placebo-controlled, Phase 3 study designed to evaluate the
efficacy and safety of BIIB059 in adult participants with active
SLE, including joint and/or skin manifestations, who are
receiving background nonbiologic lupus SOC therapy.
The study includes a screening period of up to 4 weeks; a
double-blind, placebo-controlled treatment period of 52 weeks;
and an SFU period (off-treatment) of 24 weeks (for early study
treatment terminators or the 52-week treatment period
completers who do not enter the LTE study). During the screening period,
participants who sign the ICF will undergo all
the screening procedures to determine their eligibility to
participate in the study. To enroll in the study, participants are
required to be currently treated with a stable background
nonbiologic lupus SOC therapy and to continue lupus SOC
therapy. Eligible participants will be randomized and enter the
52-week, double-blind, placebo-controlled treatment period,
during which participants will receive the assigned study
treatment SC Q4W, with an additional dose at Week 2. The last
dose of study treatment will be administered on Week 48. At the
first 3 visits with study treatment administration (Week 0,
Week 2, and Week 4), participants should remain at the study
site for at least 1 hour after administration of study treatment to
be monitored for the development of potential allergic or
anaphylactic reactions. For subsequent visits, participants will be
monitored at the discretion of the Investigator. During the study,
participants receiving OCS doses of > 5.0 mg/day of prednisone
(or equivalent) will undergo a mandatory taper.
Participants who successfully complete the 52-week treatment
period with study treatment will be considered treatment period
completers and will be offered to either participate in the LTE
study or enter the 24-week SFU. Participants who discontinue
study treatment before Week 48 will be encouraged to complete
the remaining study assessments until Week 52 and then enter
the 24-week SFU. The LTE study is not part of this study and is
planned to be developed as a separate protocol.
Intervention
Participants treated with background nonbiologic lupus SOC
therapies will be randomized 1:1:1 to receive BIIB059 450 mg,
BIIB059 225 mg, or placebo SC Q4W with an additional dose at
Week 2.
Study burden and risks
Subject*s participation in this study will last up to 80 weeks, or about half a
year, in total. This consists of a screening period (up to 4 weeks), treatment
period (52 weeks) and a follow up period (24 weeks). Throughout the study
patients will have about 22 study site visits. This includes up to 16 during
the screening and treatment period, and up to 6 during the follow up period.
COVID-19 screening needed prior to treatment would require testing and may
include an additional visit to the site.
Subjects will be expected to take the IP as instructed and patients will be
subjected to: questions regarding medical history, use of concomitant
medications/procedures and adverse events; urine sampling; measurement of vital
signs; measurement of weight/height; physical examination; skin assessments;
chest X-ray; ECGs, Nasal swab, skin photography and patient reported outcomes
questionnaires.
Subjects will be expected to not take part in other medical studies, keep
their appointments for visits, follow instructions from the study team, keep a
patient card with them at all times, not donate eggs, to use appropriate forms
of contraception and not discuss information about the study in public places
while the study is in progress,. Subjects will also be asked to complete a
diary daily with questions about your their SLE and corticosteroid treatments.
Side effects that have been seen in >= 5% of the people treated with the study
drug in 3 clinical studies are described below:
• upper respiratory tract infection
• headache
• diarrhea
• common cold
• urinary tract infection
• fall
• redness at the injection site
• joint pain
Side effects may be mild or very serious/ life-threatening. Serious side
effects that have been observed in patients treated with the study drug in one
of the previous clinical studies are hypersensitivity (allergic reaction),
meningitis, pneumonia (a type of lung infection) and epilepsy (seizure).
SLE is an autoimmune disease that affects multiple organ systems and has a
significant adverse
effect on patients* HRQoL. Currently, most therapies used to treat SLE are only
partially
effective and have considerable toxicity. Therefore, there is an unmet need for
the development
of additional efficacious therapies for SLE. The Phase 1 and Phase 2 efficacy
data from
completed BIIB059 clinical studies indicate that BIIB059 has the potential to
decrease active
lupus disease (e.g., lupus skin lesions and/or joint manifestations) and
control disease activity in
SLE, supporting the beneficial effect of BIIB059 in patients with SLE.
The data that are available to date from completed studies (Studies 230LE101,
230HV101, and
230LE201) have shown that BIIB059 had an acceptable safety profile and was well
tolerated.
Innovation House, Norden Road 70
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Innovation House, Norden Road 70
Maidenhead Berkshire SL6 4AY
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Listed location countries
Age
Inclusion criteria
Key Inclusion Criteria:
- Participant must be diagnosed with SLE at least 24weeks prior to screening
and must meet the 2019European League Against Rheumatism(EULAR)/American
College of Rheumatology (ACR)classification criteria for SLE, at screening by a
qualified physician.
- Participant has a modified Systemic Lupus Erythematosus Disease Activity
Index-200 (SLEDAI-2K) score >=6 (excluding alopecia, fever, lupus-related
headache, and organic brain syndrome) at screening (adjudicated).
- Participant has a modified clinical SLEDAI-2K score >=4 (excluding anti-
dsDNA, low complement component 3 [C3] and/or complement component 4 [C4],
alopecia, fever, lupus-related headache, and organic brain syndrome) at
screening (adjudicated) and randomization.
- Participant has BILAG-2004 grade A in >=1 organ system or BILAG-2004 grade B
in >=2 organ systems at screening (adjudicated) and randomization.
- Participants must be treated with one of the following background nonbiologic
lupus SOC therapies, initiated >=12 weeks prior to screening and at stable dose
>=4 weeks prior to randomization,
a). Antimalarials as stand-alone treatment.
b). Antimalarial treatment in combination with OCS and/or a single
immunosuppressant.
c). Treatment with OCS and/or a single immunosuppressant. Note: Other protocol
defined inclusion criteria may apply.
Exclusion criteria
- History of or positive test result for human immunodeficiency virus
(HIV).
- Current hepatitis C infection (defined as positive hepatitis C virus
[HCV] antibody and detectable HCV ribonucleic acid [RNA]).
- Current hepatitis B infection (defined as positive for hepatitis B surface
antigen [HBsAg] and/or total hepatitis
B core antibody [anti-HBc]).
- History of severe herpes infection.
- Presence of uncontrolled or New York Heart
Association class III or IV congestive heart failure.
- Active severe lupus nephritis where, in the opinion of the investigator,
protocol-specified SOC is insufficient and use of a more aggressive
therapeutic approach,
such as adding intravenous (IV) cyclophosphamide and/or high-dose IV
pulse corticosteroid therapy or other treatments not permitted in the
protocol, is indicated; or
urine protein-creatinine ratio >2.0 or severe chronic kidney disease
(estimated glomerular filtration rate <30 milliliters per minute per 1.73
meter square [mL/min/1.73
m^2]) calculated using the abbreviated Modification of Diet in Renal
Disease equation.
- Any active skin conditions other than cutaneous lupus erythematosus
(CLE) that may interfere with the study assessment of CLE such as but
not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin
lupus manifestation or drug-induced lupus.
- History or current diagnosis of a clinically significant non-SLE-related
vasculitis syndrome.
- Active neuropsychiatric SLE.
- Use of oral prednisone (or equivalent) above 20 mg/day.
Note: Other protocol defined Exclusion criteria may apply.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505696-74-00 |
| EudraCT | EUCTR2020-005776-35-NL |
| CCMO | NL78650.056.21 |