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En studie for å evaluere sikkerheten og toleransen til Dapirolizumab Pegol hos studiedeltakere med systemisk lupus erythematosus

14. oktober 2026 oppdatert av: UCB Biopharma SRL

En multisenter, åpen utvidelsesstudie for å vurdere langsiktig sikkerhet og tolerabilitet av Dapirolizumab Pegol-behandling hos studiedeltakere med systemisk lupus erythematosus

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

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

760

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Sl0046 60002
      • Mendoza, Argentina
        • Sl0046 60029
      • Quilmes, Argentina
        • Sl0046 60003
      • Quilmes, Argentina
        • Sl0046 60022
      • San Juan, Argentina
        • Sl0046 60011
      • San Miguel de Tucumán, Argentina
        • Sl0046 60014
  • Belgia
      • Brussels, Belgia
        • Sl0046 40123
  • Bulgaria
      • Plovdiv, Bulgaria
        • Sl0046 40189
      • Sofia, Bulgaria
        • Sl0046 40380
  • Canada
      • Calgary, Canada
        • Sl0046 50374
      • Edmonton AB, Canada
        • Sl0046 50337
      • Rimouski, Canada
        • Sl0046 50259
      • Toronto, Canada
        • Sl0046 50045
  • Chile
      • Santiago, Chile
        • Sl0046 60018
      • Santiago, Chile
        • Sl0046 60015
  • Colombia
      • Barranquilla, Colombia
        • Sl0046 60013
      • Barranquilla, Colombia
        • Sl0046 60019
      • Bogotá, Colombia
        • Sl0046 60006
      • Bogotá, Colombia
        • Sl0046 60027
      • Bucaramanga, Colombia
        • Sl0046 60016
      • Chía, Colombia
        • Sl0046 60007
      • Montería, Colombia
        • Sl0046 60031
  • Filippinene
      • Davao City, Filippinene
        • Sl0046 20182
      • Makati, Filippinene
        • Sl0046 20181
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • Sl0046 50140
    • Arizona
      • Avondale, Arizona, Forente stater, 85392
        • Sl0046 50058
      • Glendale, Arizona, Forente stater, 85306
        • Sl0046 50662
      • Phoenix, Arizona, Forente stater, 85032
        • Sl0046 50052
      • Tucson, Arizona, Forente stater, 85704
        • Sl0046 50328
    • California
      • Beverly Hills, California, Forente stater, 90210
        • Sl0046 50383
      • La Palma, California, Forente stater, 90623-1730
        • Sl0046 50275
      • San Leandro, California, Forente stater, 94578
        • Sl0046 50316
    • Colorado
      • Denver, Colorado, Forente stater, 80230
        • Sl0046 50339
    • Florida
      • Brandon, Florida, Forente stater, 33511
        • Sl0046 50239
      • Gainesville, Florida, Forente stater, 32610
        • Sl0046 50362
      • Miami, Florida, Forente stater, 33172
        • Sl0046 50681
      • Ormond Beach, Florida, Forente stater, 32174
        • Sl0046 50059
      • Plantation, Florida, Forente stater, 33324
        • Sl0046 50324
      • Tampa, Florida, Forente stater, 33606
        • Sl0046 50329
      • Tampa, Florida, Forente stater, 33618
        • Sl0046 50698
    • Georgia
      • Atlanta, Georgia, Forente stater, 30303
        • Sl0046 50368
    • Idaho
      • Idaho Falls, Idaho, Forente stater, 83404
        • Sl0046 50240
    • Illinois
      • Chicago, Illinois, Forente stater, 60616
        • Sl0046 50699
    • Kentucky
      • Hopkinsville, Kentucky, Forente stater, 42240-1746
        • Sl0046 50474
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70605
        • Sl0046 50285
      • New Orleans, Louisiana, Forente stater, 70112
        • Sl0046 50660
    • Maryland
      • Hagerstown, Maryland, Forente stater, 21740
        • Sl0046 50015
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Sl0046 50219
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Sl0046 50273
    • New York
      • Canton, New York, Forente stater, 13617
        • Sl0046 50366
      • Manhasset, New York, Forente stater, 11030
        • Sl0046 50264
      • New York, New York, Forente stater, 10032
        • Sl0046 50334
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28211
        • Sl0046 50238
    • Pennsylvania
      • Hershey, Pennsylvania, Forente stater, 17033
        • Sl0046 50147
    • Tennessee
      • Jackson, Tennessee, Forente stater, 38305
        • Sl0046 50001
    • Texas
      • Bellaire, Texas, Forente stater, 77401
        • Sl0046 50738
      • Colleyville, Texas, Forente stater, 76034
        • Sl0046 50418
    • West Virginia
      • Beckley, West Virginia, Forente stater, 25801
        • Sl0046 50050
  • Hellas
      • Athens, Hellas
        • Sl0046 40378
      • Athens, Hellas
        • Sl0046 40501
      • Crete, Hellas
        • Sl0046 40377
      • Larissa, Hellas
        • Sl0046 40507
  • Italia
      • Catania, Italia
        • Sl0046 40084
      • Milan, Italia
        • Sl0046 40448
  • Japan
      • Nagoya, Japan
        • Sl0046 20287
  • Kina
      • Beijing, Kina
        • Sl0046 20128
      • Changchun, Kina
        • Sl0046 20291
      • Guangzhou, Kina
        • Sl0046 20019
      • Guilin, Kina
        • Sl0046 20290
      • Shanghai, Kina
        • Sl0046 20020
      • Shantou, Kina
        • Sl0046 20346
      • Suzhou, Kina
        • Sl0046 20204
      • Tianjin, Kina
        • Sl0046 20136
      • Wenzhou, Kina
        • Sl0046 20025
      • Wuhan, Kina
        • Sl0046 20180
      • Yangzhou, Kina
        • Sl0046 20273
      • Zhengzhou, Kina
        • Sl0046 20132
  • Mexico
      • Chihuahua City, Mexico
        • Sl0046 50317
      • Cuernavaca, Mexico
        • Sl0046 50250
      • Guadalajara, Mexico
        • Sl0046 50249
      • León, Mexico
        • Sl0046 50271
      • Monterrey, Mexico
        • Sl0046 50251
      • Mérida, Mexico
        • Sl0046 50252
  • Peru
      • Lima, Peru
        • Sl0046 60023
      • Lima, Peru
        • Sl0046 60009
  • Polen
      • Bialystok, Polen
        • Sl0046 40482
      • Bydgoszcz, Polen
        • Sl0046 40119
      • Katowice, Polen
        • Sl0046 40398
      • Krakow, Polen
        • Sl0046 40502
      • Lublin, Polen
        • Sl0046 40151
      • Poznan, Polen
        • Sl0046 40044
      • Poznan, Polen
        • Sl0046 40090
      • Warsaw, Polen
        • Sl0046 40097
      • Warsaw, Polen
        • Sl0046 40098
      • Wroclaw, Polen
        • Sl0046 40397
      • Wroclaw, Polen
        • Sl0046 40481
  • Puerto Rico
      • Caguas, Puerto Rico
        • Sl0046 50671
  • Romania
      • Galati, Romania
        • Sl0046 40382
  • Serbia
      • Belgrade, Serbia
        • Sl0046 40393
      • Belgrade, Serbia
        • Sl0046 40461
      • Belgrade, Serbia
        • Sl0046 40730
      • Novi Sad, Serbia
        • Sl0046 40392
  • Spania
      • Barcelona, Spania
        • Sl0046 40160
      • Málaga, Spania
        • Sl0046 40341
      • Sabadell, Spania
        • Sl0046 40101
      • Vigo, Spania
        • Sl0046 40099
  • Sør -Korea
      • Incheon, Sør -Korea
        • Sl0046 20108
      • Seoul, Sør -Korea
        • Sl0046 20104
  • Taiwan
      • Taichung, Taiwan
        • Sl0046 20113
      • Taichung, Taiwan
        • Sl0046 20142
      • Taipei, Taiwan
        • Sl0046 20095
      • Taiyuan, Taiwan
        • Sl0046 20082
  • Tsjekkia
      • Prague, Tsjekkia
        • Sl0046 40066
  • Tyskland
      • Cologne, Tyskland
        • Sl0046 40386
      • Freiburg im Breisgau, Tyskland
        • Sl0046 40072
      • Herne, Tyskland
        • Sl0046 40027
      • Leipzig, Tyskland
        • Sl0046 40078
      • Tübingen, Tyskland
        • Sl0046 40402
      • Vogelsang-gommern, Tyskland
        • Sl0046 40715
  • Ungarn
      • Budapest, Ungarn
        • Sl0046 40412
      • Debrecen, Ungarn
        • Sl0046 40411
      • Szeged, Ungarn
        • Sl0046 40031
      • Székesfehérvár, Ungarn
        • Sl0046 40499

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dapirolizumab pegol

Subjects will receive dapriolizumab pegol throughout the Treatment Period.
Legemiddel: Dapirolizumab pegol

Subjects will receive dapirolizumab pegol at prespecified time-points.

Andre navn:
  • CDP7657
  • DZP

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of treatment-emergent adverse events (TEAEs) during the study
Tidsramme: 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.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of serious treatment-emergent adverse events during the study
Tidsramme: 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
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)
Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation
Tidsramme: 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.
From Baseline (Day 1) until Safety Follow-Up (up to Week 110)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24
Tidsramme: 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).
Week 24
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52
Tidsramme: 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).
Week 52
Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104
Tidsramme: 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).
Week 104
Achievement of LLDAS at ≥50% of all visits
Tidsramme: 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
From Baseline (Day 1) until End of Treatment (Week 104)
Achievement of BICLA response at Week 24
Tidsramme: 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.
Week 24
Achievement of BICLA response at Week 52
Tidsramme: 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.
Week 52
Achievement of BICLA response at Week 104
Tidsramme: 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.
Week 104

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UCB Biopharma SRL

Etterforskere

  • Studieleder: UCB Cares, 001 844 599 2273 (UCB)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. juli 2021

Primær fullføring (Antatt)

7. august 2030

Studiet fullført (Antatt)

7. august 2030

Datoer for studieregistrering

Først innsendt

14. juli 2021

Først innsendt som oppfylte QC-kriteriene

14. juli 2021

Først lagt ut (Faktiske)

26. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SL0046
  • 2019-003409-83 (EudraCT-nummer)
  • U1111-1293-7098 (Annen identifikator: World Health Organization (WHO))
  • 2023-506368-14 (Registeridentifikator: EU Clinical Trials)
  • 2023 (U.S. NIH-stipend/kontrakt)
  • 2019 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere