This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data. The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of litifilimab in participants with…
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of TEAEs - Number of Participants with Treatment Emergent Adverse
Events (TEAEs)
- Incidence of SAEs - Number of Participants with Serious Adverse Events (SAEs)
Secondary outcome
- Proportion of Participants who Achieved an Systemic Lupus Erythematosus
Responder Index (SRI)-4 Response by visit
- Proportion of Participants who Achieved a Joint-50 Response by visit
- Proportion of Participants who Achieved Cutaneous Lupus Erythematosus Disease
Area and Severity Index (CLASI)-50, CLASI-70,
and CLASI-90 Response by visit
- Proportion of Participants who Achieved a British Isles Lupus Assessment
Group based Composite Lupus Assessment (BICLA)
Response by visit
- Annualized Severe Safety of Estrogens in Systemic Lupus Erythematosus
National Assessment - Systemic Lupus Erythematosus
Disease Activity Index Flare Index (SFI) Flare Rate where severe flare is
defined using the SFI definition (Appendix B of the Protocol)
- Percentage of Time Spent in Lupus Low Disease Activity State (LLDAS)
- Proportion of participants with sustained LLDAS
- Duration of Sustained LLDAS as Defined by the Number of Visits in LLDAS up to
Week 180
- Annual Change From Baseline Value From the Parent Phase 3 Studies in Systemic
Lupus International Collaborating Clinics/American College of
Rheumatology Damage Index (SDI) Score
- Cumulative Exposure to OCS Over Time
- Percentage of Participants With OCS <=7.5 mg by visit
- Percentage of Participants With OCS <=5 mg up by visit
- Participant-reported outcome measures: LupusQoL, SF-36 (Acute Version),
EQ-5D-3L, FACIT-Fatigue, PHQ-9, WPAI:Lupus, and PtGA
- Change in standard laboratory parameters and ECG results
- Incidence of antibodies to litifilimab
Background summary
BIIB059 is a type of antibody (a substance that is made by the immune system)
that has been developed in a lab to be used in people. The study drug has been
developed to target certain cells that are thought to play a role in the
development of lupus. It is hoped the study drug can improve symptoms in people
who have SLE.
Earlier research studies have already looked at whether the study drug was safe
for people with SLE, and whether it helped to control their symptoms. Based on
the positive results from earlier studies, the researchers now want to know
whether the study drug works better when given for a longer period of time.
Study objective
This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data.
The Primary Objective of this Clinical Trial is to evaluate the long-term
safety and tolerability of litifilimab in participants with active SLE.
The Secondary Objectives of this Clinical Trial are:
- to evaluate the long-term effect of litifilimab on disease activity in
participants with SLE
- to evaluate the long-term effect of litifilimab in participants with SLE in
maintaining low disease activity
- to evaluate the effect of litifilimab in participants with active SLE in
preventing irreversible organ damage
- to assess long-term use of OCS6 with participants receiving litifilimab
treatment
- to assess the impact of litifilimab on participant-reported HRQoL, symptoms
and impacts of SLE
- to evaluate long-term effect of litifilimab on laboratory parameters
- to evaluate immunogenicity of litifilimab
Study design
This is a multicenter, randomized, parallel-group, dose-blind, Phase 3 LTE
study. This study will be conducted in participants who completed the 52-week
duration of Study 230LE303 or Study 230LE304 on study treatment. Participants
who were treated with BIIB059 in the parent Phase 3 studies will continue to
receive BIIB059 treatments SC Q4W through the duration of this LTE study, in
addition to at least 1 of the following nonbiologic lupus SOC therapies:
antimalarials, OCS, or immunosuppressants.
Intervention
In this LTE study, participants who received randomized low dose BIIB059 and
high dose BIIB059 SC Q4W during the parent Phase 3 studies will continue their
respective doses. There will be no placebo arm as a comparator in this LTE.
Participants who had received placebo during the parent Phase 3 studies will be
randomized 1:1 in this LTE study to receive low dose BIIB059 or high dose
BIIB059 SC Q4W with an additional corresponding dose at Week 2, as an add-on
to background nonbiologic lupus SOC therapy. Participants will remain on their
assigned dose of BIIB059 throughout the LTE study.
Study burden and risks
The treatment period will last for 152 weeks. Participants will have to visit
the study center every month (every 4 weeks) up to Week 24, as well as at Week
2, Week 36, and Week 52. After Week 52, participants will have to visit the
study center every 12 to 16 weeks up to Week 156. There will be at least 18
study visits. During these visits, participants will complete the study
assessments and receive the study drug. In addition, participants will have to
visit the study site every 4 weeks between these 18 visits, to receive study
treatment but participants will not have study assessments with these visits.
Once the participant finish the study treatment period, the participant will
enter the follow-up period after your End-of-Treatment visit. This is to check
how the participant is doing after completing the study treatment period. The
follow-up period lasts for 24 weeks. The participant will visit the study
center 4 times and be contacted by the study team via telephone twice during
this time.
Subjects will be expected to take the IP as instructed and patients 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;
ECGs 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 aredescribed 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 patientstreated 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).
Side effects may be mild or very serious/ life-threatening. Serious side
effects that have been observed in patients treated with thestudy drug in one
of the previous clinical studies are hypersensitivity (allergic reaction),
meningitis, pneumonia (a type of lunginfection) 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 have shown that
BIIB059 had an acceptable safety profile and was well tolerated.
Innovation House, Norden Road 70
Maidenhead, Berkshire SL6 4AY
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Innovation House, Norden Road 70
Maidenhead, Berkshire SL6 4AY
GB
Listed location countries
Age
Inclusion criteria
1. Participants who completed 1 of the 52-week of the double-blind
placebo-controlled,
parent Phase 3 studies (230LE303 and 230LE304) on study treatments with either
BIIB059 or placebo to Week 48 and attended the last study assessment visit at
Week 52.
2. Ability of the participant to understand the purpose and risks of the
study, to provide informed consent, and to authorize the use of
confidential health information in accordance with national and local
privacy regulations.
3. All women of childbearing potential must agree to practice highly effective
contraception during
the study and for 126 days (18 weeks) after their last dose of study treatment.
In addition,
participants should not donate eggs during the study and for at least 126 days
(18 weeks)
after their last dose of study treatment. Where applicable, if not previously
confirmed in
the parent Phase 3 study, postmenopausal status must be confirmed as follows:
for
women <= 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea
without an alternative medical cause and a serum FSH level >= 40 mIU/mL; for
women
> 55 years of age, 52 continuous weeks of natural (spontaneous) amenorrhea
without an
alternative medical cause and a serum FSH level >= 40 mIU/mL, or at least 5
continuous
years of natural (spontaneous) amenorrhea without an alternative medical cause.
Exclusion criteria
1. Early parent Phase 3 studies treatment terminators (participants who
discontinued study treatment before Week 52).
2. Early parent Phase 3 studies terminators (participants who withdrew from
study participation and did not complete the 52-week treatment period).
3. Participants who have developed any other medical diseases, conditions, or
abnormalities, rendering their participation in the LTE study unsuitable in the
opinion of the Investigator.
4. Participants who developed moderate-to-severe worsening of organ specific
lupus manifestations that would require a change in immunosuppressive therapy.
5. Use of prohibited concurrent medication or therapy during the parent Phase 3
studies.
6. Immunization with live or live-attenuated vaccines within 4 weeks prior to
Baseline Visit.
7. Use of other investigational drugs or off-label drugs used to treat SLE,
cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.
8. Female participants who are pregnant, currently breastfeeding, or planning
to become pregnant during the study and for 126 days (18 weeks) after the last
dose of study treatment.
9. Current enrollment or a plan to enroll in any interventional clinical study
in which an investigational treatment or approved therapy for investigational
use is administered (participation in observational registries is allowed).
10. Inability to comply with study requirements.
11. Other unspecified reasons that, in the opinion of the Investigator or
Sponsor, make the participant unsuitable for enrollment.
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 | CTIS2023-505635-13-00 |
| EudraCT | EUCTR2021-006378-22-NL |
| ClinicalTrials.gov | NCT05352919 |
| CCMO | NL82387.056.22 |