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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japon, 113-8519
- Recrutement
- Institute of Science Tokyo Hospital /ID# 279648
-
-
-
-
Alabama
-
Anniston, Alabama, États-Unis, 36207
- Recrutement
- Pinnacle Research Group /ID# 278677
-
-
California
-
Tustin, California, États-Unis, 92780
- Recrutement
- Solace Research /ID# 279155
-
-
Florida
-
Clearwater, Florida, États-Unis, 33765
- Recrutement
- Clinical Research Of West Florida - Phase I Unit /ID# 279292
-
Greenacres City, Florida, États-Unis, 33467
- Recrutement
- Finlay Medical Research - Greenacres /ID# 278380
-
Kissimmee, Florida, États-Unis, 34741
- Recrutement
- Clinical Research of Osceola /ID# 278374
-
Plantation, Florida, États-Unis, 33317
- Recrutement
- Discovery Health Research Center /ID# 279691
-
Tampa, Florida, États-Unis, 33606
- Recrutement
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
-
-
Illinois
-
Orland Park, Illinois, États-Unis, 60462
- Recrutement
- Advanced Quality Medical Research /ID# 279147
-
-
Texas
-
Red Oak, Texas, États-Unis, 75154
- Recrutement
- Epic Medical Research /ID# 279180
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1: Dose A
Participants will receive a single intravenous (IV) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Expérimental: Group 2: Dose B
Participants will receive a single intravenous (IV) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Expérimental: Group 3: Dose C
Participants will receive a single intravenous (IV) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Expérimental: Group 4: Dose D
Participants will receive a single subcutaneous (SC) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
|
Expérimental: Group 5: Dose E
Participants will receive a single subcutaneous (SC) dose of ABBV-519
|
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in B Cells in Blood
Délai: Up to 365 Days
|
Change from baseline in B cells in blood.
|
Up to 365 Days
|
|
Maximum Plasma Concentration (Cmax) of ABBV-519.
Délai: Up to 85 Days
|
Cmax of ABBV-519
|
Up to 85 Days
|
|
Time to Cmax (Tmax) of ABBV-519
Délai: Up to 85 Days
|
Tmax of ABBV-519
|
Up to 85 Days
|
|
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M25-989
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .