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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of dapirolizumab pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SL0044 PHOENYCS FLY)

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Matano Mizuho

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023

CTR-JRCT.UCBJapan@ucb.com

Global Clinical Science & Operation

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Recruiting

Dec. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Study participant must be >=16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
- Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:
a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician
b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following:
i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory)
ii) Either complement C3 <lower limit of normal (LLN) OR complement C4 <LLN as measured by central laboratory
iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:
1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)
2. Anti-Sjogren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjogren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)
3. Historical evidence for anti-dsDNA antibodies
4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory)
d. Moderately to severely active defined as:
-British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in >=2 organ systems and/or a BILAG 2004 Grade A in >=1 organ systems at Screening and Baseline Visit
AND
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) >=6 at the Screening Visit
AND
- SLEDAI-2K without labs >=4 at Baseline Visit
e. Receiving the following standard of care (SOC) medications at stable dose:
- Antimalarial treatment in combination with corticosteroids and/or immunosuppressants or as stand-alone treatment if justified
OR
- Treatment with corticosteroids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life threatening condition
- Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy
- Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection [eg, curettage, electrodesiccation] not later than 4 weeks prior to the Screening Visit [V1]), basal cell carcinoma, or dermatological squamouscell carcinoma
- Study participant has an increased risk for thromboembolic events due to an ongoing heart disease or due to a medical device, including but not limited to vascular graft, valvular heart disease, atrial fibrillation, or a heart rhythm disorder
- Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE
- Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study
- Study participant has clinically significant active or latent infection
- Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis,
cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection
- Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion
- Study participant has used the prohibited medications defined in the Protocol
- Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol in a study evaluating dapirolizumab pegol
- Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP
- Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2, or serum creatinine >2.5 mg/dL, or participant has proteinuria >3g/day, or protein:creatinine ratio >340 mg/mmol at the Screening Visit

Both

Systemic lupus erythematosus (SLE)

Study participants will receive dapirolizumab pegol calculated per body weight at pre-specified timepoints.
Study participants will receive placebo at pre-specified timepoint.

Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 48

1. Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 24
2. Achievement of British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004)-based Composite Lupus Assessment (BICLA) response at Week 12
3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 48
4. Achievement of LLDAS in >=50% of post Baseline visits through Week 48
5. Change from Baseline in SLEDAI-2K at Week 48
6. Achievement of BILAG 2004 improvement without worsening at Week 48
7. Change from Baseline in PGA at Week 48
8. Achievement of SRI 4 response at Week 48
9. Achievement of prevention of moderate/severe BILAG flares (moderate/severe BILAG flarefree) through Week 48
10. Time to severe BILAG flare through Week 48
11. Time to moderate/severe BILAG flare through Week 48
12. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
13. Percentage of participants with serious treatment-emergent adverse events during the study
14. Percentage of participants with treatment-emergent adverse events of special interest during the study
15. Percentage of participants with treatment-emergent adverse events of special monitoring during the study

+81-956-33-7151

Aug. 09, 2022

Yes

Plan Description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available. IPD Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. IPD Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. IPD URL https://www.vivli.org

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