M32 Systemic lupus erythematosus Systemic lupus erythematosus
Conditions
Interventions
Litifilimab (BIIB059) 450 mg, every 4 weeks. The treatment period is 156 weeks. Administered subcutaneously - Litifilimab (BIIB059) 225 mg, every 4 weeks. The treatment period is 156 weeks. Administer
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 litifilimab 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. See further contraception instructions in the guidance text in Section 11.4.1 (Pregnancy) and Section 11.5 (Contraception).
Exclusion criteria
Exclusion criteria: 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. 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 antimalarials and/or immunosuppressive therapy (initiation of new treatment or increase in dose above the allowed maximum dose as specified in Table 3 and Table 4, since the preceding scheduled study visit, and not previously discussed with the Sponsor). 5. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies (Table 6). 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of TEAEs 2. Incidence of SAEs NAME OF THE RESULT: To evaluate the long-term safety andtolerability of litifilimab in participants with active SLE PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1. Through end of Treatment 2. Through end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of TEAEs 2. Incidence of SAEs NAME OF THE RESULT: To evaluate the long-term safety andtolerability of litifilimab in participants with active SLE PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1. Through end of Treatment 2. Through end of treatment;1. Proportion of participants who achieved an SRI-41 response by visit 2. Proportion of participants who achieved a Joint-502,3 response by visit 3.Proportion of participants who achieved CLASI-50, CLASI-70, and CLASI-90 response by visit 4. Proportion of participants who achieved a BICLA response by visit 4. 5. Annualized severe SFI Flare Rate where severe flare is defined using the SFI definition (Appendix B) NAME OF THE RESULT: To evaluate the long-term effect of litifilimab on disease activity in participants with SLE PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1. Through end of Treatment 2. Through end of Treatment 3. Through end of Treatment 4. Through end of Treatment 5. Through end of Treatment;1. Percentage of time spent in LLDAS 5 2. Proportion of participants with sustained LLDAS 3.Duration of sustained LLDAS as defined by the number of visits in LLDAS NAME OF THE RESULT: To evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1. Through end of Treatment 2. Through end of Treatment 3. Through end of Treatment;Annual change from baseline value from the parent Phase 3 studies in SDI score NAME OF THE RESULT: To evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Through end of Treatment;1. Cumulative exposure to OCS over time 2. Proportion of participants with OCS = 7.5 m | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Korea South, Mexico, Nederland, Peru, Philippines, Poland, Romania, Serbia, Spain, Sweden, Taiwan, United Kindgdom, United States
Contacts
Public ContactMiriam Luz Vargas
IQVIA RDS PERU S.R.L.
Outcome results
None listed