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)
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: ABBVIE CALL CENTER
- Telefonnummer: 844-663-3742
- E-post: abbvieclinicaltrials@abbvie.com
Studiesteder
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Rekruttering
- Pinnacle Research Group /ID# 278677
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California
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Tustin, California, Forente stater, 92780
- Rekruttering
- Solace Research /ID# 279155
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Florida
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Clearwater, Florida, Forente stater, 33765
- Rekruttering
- Clinical Research Of West Florida - Phase I Unit /ID# 279292
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Greenacres City, Florida, Forente stater, 33467
- Rekruttering
- Finlay Medical Research - Greenacres /ID# 278380
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Kissimmee, Florida, Forente stater, 34741
- Rekruttering
- Clinical Research of Osceola /ID# 278374
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Plantation, Florida, Forente stater, 33317
- Rekruttering
- Discovery Health Research Center /ID# 279691
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Tampa, Florida, Forente stater, 33606
- Rekruttering
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
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Illinois
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Orland Park, Illinois, Forente stater, 60462
- Rekruttering
- Advanced Quality Medical Research /ID# 279147
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Texas
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Red Oak, Texas, Forente stater, 75154
- Rekruttering
- Epic Medical Research /ID# 279180
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 113-8519
- Rekruttering
- Institute of Science Tokyo Hospital /ID# 279648
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group 1: Dose A
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Eksperimentell: Group 2: Dose B
Participants will receive a single intravenous (IV) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Eksperimentell: Group 3: Dose C
Participants will receive a single intravenous (IV) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Eksperimentell: Group 4: Dose D
Participants will receive a single subcutaneous (SC) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
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Eksperimentell: Group 5: Dose E
Participants will receive a single subcutaneous (SC) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in B Cells in Blood
Tidsramme: Up to 365 Days
|
Change from baseline in B cells in blood.
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Up to 365 Days
|
|
Maximum Plasma Concentration (Cmax) of ABBV-519.
Tidsramme: Up to 85 Days
|
Cmax of ABBV-519
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Up to 85 Days
|
|
Time to Cmax (Tmax) of ABBV-519
Tidsramme: Up to 85 Days
|
Tmax of ABBV-519
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Up to 85 Days
|
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Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
Tidsramme: Up to 85 Days
|
t1/2 of ABBV-519
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Up to 85 Days
|
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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
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Percentage of participants with detection of ADAs for ABBV-519
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Up to 169 Days
|
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: ABBVIE INC., AbbVie
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M25-989
Plan for individuelle deltakerdata (IPD)
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