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Enrolling by Invitation

NCT Number: NCT04976322

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

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

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sl0046 60002, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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 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

Treatment and study plan

Dapirolizumab pegol

Drug

Subjects will receive dapirolizumab pegol at prespecified time-points.

Other names: DZP, CDP7657

Primary outcomes

  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, and leading to permanent drug discontinuation whether or not these events are related to study treatment.

Secondary outcomes

  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:

    • 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
    • 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
    • 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:

    • 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
    • No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    • 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:

    • 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
    • No worsening in the SLEDAI-2K total score compared to Baseline Visit (defined as no increase in SLEDAI-2K total score); and
    • 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.

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Jul 26, 2021
Registry last updated
Jul 24, 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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