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NCT Number: NCT06044337

A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus

In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue.

The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301.

The main objective of the study is to learn more about the long-term safety of litifilimab.

The main question researchers want to answer is:

* How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug.

Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).

Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab.

The study will be done as follows:

* The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.

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Key information

Conditions

Subacute Cutaneous Lupus Erythematosus Chronic Cutaneous Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto CAICI, Rosario, Santa Fe Province, Argentina

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About this study

The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with SLE; to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Participants who completed the parent study (230LE301 [NCT05531565], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
  • 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.

Key Exclusion Criteria:

  • Early Part A or Part B parent study (230LE301 [NCT05531565]) treatment terminators (participants who discontinued study treatment before Week 48).
  • Early Part A or Part B parent study terminators [participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)].
  • Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

BIIB059 (litifilimab)

Drug

Administered as specified in the treatment arm.

Other names: litifilimab

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 232 weeks

Secondary outcomes

  1. Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Time frame: Up to 232 weeks

  2. Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Time frame: Up to 232 weeks

  3. Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565])

    Time frame: Up to 232 weeks

  4. Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1

    Time frame: Up to 232 weeks

  5. Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0

    Time frame: Up to 232 weeks

  6. Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline

    Time frame: Day 1 (LTE Baseline) up to Up to 232 weeks

  7. Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  8. Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  9. Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at LTE Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  10. Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study)

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  11. Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  12. Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  13. Percentage of Participants who Achieve a CLASI A Score of 0 to 3

    Time frame: Up to 232 weeks

  14. Percentage of Participants who Achieve a CLASI-A Score of 0 to 5

    Time frame: Up to 232 weeks

  15. Percentage of Participants With a CLASI-A 0 to 3 Response Among CLASI-A 0 to 3 Responders at LTE Baseline

    Time frame: Day 1 (LTE Baseline) up to 232 weeks

  16. Absolute Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208

    Time frame: Day 1 (Baseline of Parent study) up to 208 weeks

  17. Percent Change From Baseline in CLASI-A Score of Parent Study (NCT05531565) to Week 208

    Time frame: Day 1 (Baseline of Parent study) up to 208 weeks

  18. Absolute Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index Damage (CLASI-D) Score From Baseline Value (Parent Study [NCT05531565]) to Week 208

    Time frame: Up to 208 weeks

  19. Percent Change in CLASI-D Score From Baseline Value (Parent Study [NCT05531565]) to Week 208

    Time frame: Up to 208 weeks

  20. Annualized Mild/Moderate and Severe Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index Flare Index (SFI) Rates

    Time frame: Up to 208 weeks

  21. Percentage of Participants With Oral Corticosteroid (OCS) Dose Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Time frame: Day 1 (Baseline of Parent study) up to 208 weeks

  22. Percentage of Participants With OCS ≤ 7.5 Milligrams per day (mg/day) Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Time frame: Day 1 (Baseline of Parent study) up to 208 weeks

  23. Percentage of Participants With OCS ≤ 5.0 mg/day Among Participants who Used OCS at Baseline in the Parent Study (NCT05531565)

    Time frame: Day 1 (Baseline of Parent study) up to 208 weeks

  24. Change From Baseline Value (Parent Study [NCT05531565]) in Cutaneous Lupus Erythematosus - Quality of Life (CLE-QoL) at Week 208

    Time frame: Baseline, Week 208

  25. Change From Baseline Value (Parent Study [NCT05531565]) in European Quality of Life - 5-Dimensions Questionnaire, 3-Level Version (EQ-5D-3L) at Week 104

    Time frame: Baseline, Week 104

  26. Change From Baseline Value (Parent Study [NCT05531565]) in 36-Item Short Form Survey (SF-36) (acute version) at Week 104

    Time frame: Baseline, Week 104

  27. Change From Baseline Value (Parent Study [NCT05531565]) in Work Productivity and Activity Impairment (WPAI): Lupus at Week 104

    Time frame: Baseline, Week 104

  28. Change From Baseline Value (Parent Study [NCT05531565]) in Patient Health Questionnaire-9 (PHQ-9) at Week 104

    Time frame: Baseline, Week 104

  29. Change From Baseline Value (Parent Study [NCT05531565]) in Subject Global Assessment of Skin - Follow-up (SGA-Skin-FU) at Week 208

    Time frame: Baseline, Week 208

  30. Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Pain in Skin Rash at Week 208

    Time frame: Baseline, Week 208

  31. Change From Baseline Value (Parent Study [NCT05531565]) in Numerical Rating Scale (NRS) for Itch in Skin Rash at Week 208

    Time frame: Baseline, Week 208

  32. Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Standard Laboratory Parameters

    Time frame: Up to 208 weeks

  33. Number of Participants With Clinically Relevant Change From Baseline Value (Parent Study [NCT05531565]) in Electrocardiogram (ECG) Results

    Time frame: Up to 232 weeks

  34. Number of Participants With Anti-BIIB059 Antibodies in Serum

    Time frame: Up to 232 weeks

  35. Serum Concentration of Litifilimab

    Time frame: Pre-dose up to 232 weeks

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy

Acronym: AMETHYST LTE

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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