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A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

29. maj 2026 opdateret af: AbbVie

A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.

This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • Trukket tilbage
        • UCLA Health West Medical Campus /ID# 282811
      • Tustin, California, Forenede Stater, 92780
        • Rekruttering
        • Solace Research /ID# 279155
    • Florida
      • Greenacres City, Florida, Forenede Stater, 33467
        • Rekruttering
        • Finlay Medical Research - Greenacres /ID# 278380
      • Plantation, Florida, Forenede Stater, 33317
        • Rekruttering
        • Discovery Health Research Center /ID# 279691
    • Texas
      • Red Oak, Texas, Forenede Stater, 75154
        • Rekruttering
        • Epic Medical Research /ID# 279180

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Key Inclusion Criteria:

  • Individuals between 18 and 75 years of age inclusive at the time of Screening.
  • Minimum baseline B-cell count of 50 cells/mcL.

Inclusion Criteria for SLE Participants:

  • Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
  • Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
  • Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
  • Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.

Inclusion Criteria for RA Participants:

  • Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
  • Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
  • Presence of at least 6 swollen and 6 tender joints
  • High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
  • Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.

Exclusion Criteria:

Key Exclusion Criteria:

  • Participants with a history of infection.
  • Participants with uncontrolled hypertension

Exclusion for SLE Participants:

  • Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).

    - Unstable or progressive glomerulonephritis (active class III or IV).

  • SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.

Exclusion for RA Participants:

-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: Dose A
Participants will receive a single intravenous (IV) dose of ABBV-519
Medicin: ABBV-519
Intravenous (IV) Infusion
Medicin: ABBV-519
Subcutaneous (SC) Injection
Eksperimentel: Group 2: Dose B
Participants will receive a single intravenous (IV) dose of ABBV-519
Medicin: ABBV-519
Intravenous (IV) Infusion
Medicin: ABBV-519
Subcutaneous (SC) Injection
Eksperimentel: Group 3: Dose C
Participants will receive a single intravenous (IV) dose of ABBV-519
Medicin: ABBV-519
Intravenous (IV) Infusion
Medicin: ABBV-519
Subcutaneous (SC) Injection
Eksperimentel: Group 4: Dose D
Participants will receive a single subcutaneous (SC) dose of ABBV-519
Medicin: ABBV-519
Intravenous (IV) Infusion
Medicin: ABBV-519
Subcutaneous (SC) Injection
Eksperimentel: Group 5: Dose E
Participants will receive a single subcutaneous (SC) dose of ABBV-519
Medicin: ABBV-519
Intravenous (IV) Infusion
Medicin: ABBV-519
Subcutaneous (SC) Injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in B Cells in Blood
Tidsramme: Up to 365 Days
Change from baseline in B cells in blood.
Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.
Tidsramme: Up to 85 Days
Cmax of ABBV-519
Up to 85 Days
Time to Cmax (Tmax) of ABBV-519
Tidsramme: Up to 85 Days
Tmax of ABBV-519
Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
Tidsramme: Up to 85 Days
t1/2 of ABBV-519
Up to 85 Days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
Tidsramme: Up to 85 Days
AUCt of ABBV-519
Up to 85 Days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
Tidsramme: Up to 169 Days
Percentage of participants with detection of ADAs for ABBV-519
Up to 169 Days
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to 425 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to 425 Days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Efterforskere

  • Studieleder: ABBVIE INC., AbbVie

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. maj 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. januar 2029

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M25-989

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med ABBV-519

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