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A Study to Evaluate the Safety and Tolerability of Dapirolizumab Pegol in Study Participants With Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT04976322
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2021
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief Summary:
The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Dapirolizumab pegol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Dapirolizumab pegol
Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Drug: Dapirolizumab pegol
Subjects will receive dapirolizumab pegol at prespecified time-points.
Other Names:
  • DZP
  • CDP7657




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110) ]
    Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

  2. Incidence of serious treatment-emergent adverse events during the study [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110) ]

    A serious treatment-emergent adverse event (serious TEAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires in patient hospitalisation or prolongation of existing hospitalisation
    • Results in persistent disability/incapacity
    • Is a congenital anomaly or birth defect
    • Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above

  3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation [ Time Frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 110) ]
    Treatment-emergent adverse events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.


Secondary Outcome Measures :
  1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24 [ Time Frame: Week 24 ]
    BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).

  2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52 [ Time Frame: Week 52 ]
    BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).

  3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 [ Time Frame: Week 104 ]
    BILAG severe flare is defined as a new British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade A since previous visit in any system due to individual items that are new or worse qualifying for the Grade A (Isenberg et al, 2011). Determination of items that are new or worse qualifying for the Grade A will be according to the supplementary information for the numerical scoring of the BILAG-2004 index (Yee et al, 2010).

  4. Achievement of LLDAS at ≥50% of all visits [ Time Frame: From Baseline (Day 1) until End of Treatment (Week 104) ]

    Low lupus disease activity state (LLDAS) is defined as:

    • No significant disease activity as per SLEDAI-2K and BILAG 2004 (SLEDAI-2K score ≤4 with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever)
    • No new and/or worsening disease activity defined as no SLEDAI-2K component documented as present that was not documented present at previous visit
    • PGA ≤33 mm
    • Prednisone equivalent systemic dose for systemic lupus erythematosus (SLE) indication ≤7.5 mg per day
    • Stable standard maintenance doses of immunosuppressive drugs as allowed by protocol

  5. Achievement of BICLA response at Week 24 [ Time Frame: Week 24 ]

    A study participant is considered to be a BILAG 2004-based Composite Lupus Assessment (BICLA) responder if all of the following is fulfilled:

    1. British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
    2. No worsening in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    3. No worsening in the Physician's Global Assessment of Disease (PGA) compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

    The parent studies Baseline will be used as reference point.


  6. Achievement of BICLA response at Week 52 [ Time Frame: Week 52 ]

    A study participant is considered to be a BICLA responder if all of the following is fulfilled:

    1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
    2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

    The parent studies Baseline will be used as reference point.


  7. Achievement of BICLA response at Week 104 [ Time Frame: Week 104 ]

    A study participant is considered to be a BICLA responder if all of the following is fulfilled:

    1. BILAG 2004 improvement without worsening (A scores at Baseline improved to B, C or D; B scores improved to C or D; no new A scores and ≤1 new B.); and
    2. No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    3. No worsening in the PGA compared to Baseline Visit defined as ≤10 mm increase on a 100 mm visual analog scale

    The parent studies Baseline will be used as reference point.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment
  • The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study

Exclusion Criteria:

- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (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 or ongoing malignancies at the start of the study


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): NCT04976322


Locations
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United States, Idaho
Sl0044 50240
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04976322    
Other Study ID Numbers: SL0046
2019-003409-83 ( EudraCT Number )
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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.
URL: https://www.Vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Systemic lupus erythematosus
Dapirolizumab pegol
SLE
DZP
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases