A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus (EMERALD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Biogen Idec Research Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Jun 2022 → ongoing

Decision date (initial)

2024-07-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-505635-13-00

EudraCT number

2021-006378-22

ClinicalTrials.gov

NCT05352919

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacodynamic, Efficacy, Others

To evaluate the long-term safety and tolerability of litifilimab in participants with active SLE

Substudy:
To evaluate the safety of OBI used for administering litifilimab in participants with active SLE.

Secondary objectives 8

1. to evaluate the long-term effect of litifilimab on disease activity in participants with SLE
2. to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity
3. to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage
4. to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment
5. to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE
6. to evaluate long-term effect of litifilimab on laboratory parameters
7. to evaluate immunogenicity of litifilimab
8. Substudy: To evaluate the tolerability of OBI used for administering litifilimab in participants with active SLE.

Conditions and MedDRA coding

Systemic lupus erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants who completed 1 of the 52-week of the double-blind placebo-controlled, parent Phase 3 studies (230LE303 (NCT04895241) and 230LE304 (NCT04961567)) 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.

Exclusion criteria 11

1. Early parent Phase 3 studies treatment terminators (participants who discontinued study treatment before Week 52)
2. 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.
3. 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).
4. Inability to comply with study requirements.
5. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrolment.
6. Early parent Phase 3 studies terminators (participants who withdrew from study participation and did not complete the 52-- week treatment period)
7. 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.
8. 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).
9. Use of prohibited concurrent medication or therapy during the parent Phase 3 studies
10. Immunization with live or live-attenuated vaccines within 4 weeks prior to Baseline Visit.
11. Use of other investigational drugs or off-label drugs used to treat SLE, cutaneous lupus, or lupus nephritis during the parent Phase 3 studies.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of Treatment Emergent Adverse Events (TEAEs)
2. Number of Serious Adverse Events (SAEs)

Secondary endpoints 15

1. Proportion of participants who achieved an SRI-4 response by visit
2. Proportion of participants with at least 4 joints (both swollen and tender) at baseline who achieved a Joint-50 response by visit
3. Proportion of participants with a CLASI-A score ≥ 10 at baseline who achieved a 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
6. Percentage of time spent in LLDAS 5
7. Proportion of participants with sustained LLDAS
8. Duration of sustained LLDAS as defined by the number of visits in LLDAS
9. Annual change from baseline value from the parent Phase 3 studies in SDI score
10. Cumulative exposure to OCS over time
11. Proportion of participants with OCS ≤ 7.5 mg by visit
12. Proportion of participants with OCS ≤ 5 mg by visit
13. Participant-reported outcome measures: LupusQoL, SF-36 (Acute Version), EQ-5D-3L, FACIT-Fatigue, PHQ-9, WPAI:Lupus, and PtGA
14. Change in standard laboratory parameters and ECG results
15. Incidence of antibodies to litifilimab

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biogen Idec Research Limited

Sponsor organisation

Biogen Idec Research Limited

Address

Building 5 Foundation Park, Roxborough Way Roxborough Way

City

Maidenhead

Postcode

SL6 3UD

Country

United Kingdom

Scientific contact point

Organisation

Biogen Idec Research Limited

Contact name

Clinical Trials Information Desk

Public contact point

Organisation

Biogen Idec Research Limited

Contact name

Clinical Trials Information Desk

Third parties 7

Locations

13 EU/EEA countries · 46 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 187 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

10 submissions — initial application plus substantial / non-substantial modifications