Study of VIB7734 for the Treatment of Moderate to Severely Active SLE (RECAST SLE)
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| ClinicalTrials.gov Identifier: NCT04925934 |
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Recruitment Status :
Completed
First Posted : June 14, 2021
Last Update Posted : February 28, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Erythematosus, Systemic | Drug: VIB7734 Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 214 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomized, double-blind, placebo-controlled, parallel-arm study |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus |
| Actual Study Start Date : | June 24, 2021 |
| Actual Primary Completion Date : | May 16, 2023 |
| Actual Study Completion Date : | June 9, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
MedlinePlus related topics:
Lupus
| Arm | Intervention/treatment |
|---|---|
| Experimental: VIB7734 SC (dosing interval 1) |
Drug: VIB7734
VIB7734
Other Names:
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| Experimental: VIB7734 SC (dosing interval 2) |
Drug: VIB7734
VIB7734
Other Names:
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| Placebo Comparator: Placebo SC (dosing interval 3) |
Other: Placebo
Placebo |
Primary Outcome Measures :
- Proportion of Participants who achieve BICLA and OGC (oral glucocorticoid) reduction response at Week 48 [ Time Frame: Week 48 ]Participants will have BICLA (BILAG 2004 Index-Based Combined Lupus Assessment) and oral glucocorticoid assessment at week 48.
Secondary Outcome Measures :
- Proportion of Participants with CLASI-A score ≥ 10 at Baseline (Day 1) who achieve ≥ 50% reduction from Baseline (Day 1) in CLASI-A score at Week 12 [ Time Frame: Week 12 ]Cutaneous Lupus Erythematosus Disease Area and Severity Index will be measured at week 12. The scoring consists of 2 parts: inflammatory activity of the disease and damage done by the disease.
- Proportion of Participants achieving an SRI-4 response and an OGC dose ≤ 7.5 mg/day and ≤ Baseline (Day 1) dose of prednisone or equivalent at Week 48 [ Time Frame: Week 48 ]The SRI-4 (SLE Responder Index) is defined as meeting all criteria compared to baseline, (e.g. no worsening of symptoms).
- Proportion of Participants at OGC dose ≥ 10 mg prednisone or equivalent at Baseline (Day 1) who achieve an OCG of ≤ 7.5 mg/day prednisone or equivalent at Week 36 through Week 48 [ Time Frame: Week 36 to Week 48 ]
- Proportion of Participants achieving LLDAS (Lupus Low Disease Activity State) at Week 48 [ Time Frame: Week 48 ]LLDAS is a composite measure of SLE disease activity that measures 5 criteria: SLEDAI-2K ≤ 4, with no activity in major organ systems, no new lupus disease activity, PGA ≤ 1 (scale 0 to 3), current prednisone (or equivalent) dose ≤ 7.5 mg daily, tolerated maintenance doses of immunosuppressive drugs and approved biological agents.
Other Outcome Measures:
- Number of Participants who experience AEs, SAEs, AESIs [ Time Frame: Baseline through Week 56 ]Safety evaluation will occur throughout the study.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years to ≤ 70 years
- Willing and able to understand and provide written informed consent.
- Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
- Disease duration of at least 6 months
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Active SLE as indicated by presence of all the following:
- SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
- SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
- At least one of the following BILAG 2004 Index levels of disease at Screening:
- BILAG A disease in ≥ 1 organ system
- BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening
Have at least one of the following at Screening per central lab:
- ANA ≥ 1:80
- Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
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Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE
- Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
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Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
- Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.
- Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.
Exclusion Criteria:
- Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
- History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
- Active LN or active severe or unstable neuropsychiatric SLE
- Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
- Participation in another clinical study with an investigational drug within 4 weeks before Day 1
- Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
- Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
- Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
- Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
- Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
- History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.
- History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
- Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable
- The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04925934
Locations
Show 67 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | Nisha Jain, MD | Horizon Therapeutics |
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT04925934 |
| Other Study ID Numbers: |
VIB7734.P2.S1 2020-005528-12 ( EudraCT Number ) |
| First Posted: | June 14, 2021 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |