A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT03978520Tipo: INTERVENTIONALInicio: 25 de jul de 2019Fin estimado: 14 de jul de 2022

Traducción no disponible, mostrando original

Resumen

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
At Screening, must have at least one of the following:
antinuclear antibody (ANA)+ (titer ≥ 1:80)
anti-dsDNA+
anti-Smith+
SLEDAI-2K (SLE Disease Activity Index) ≥ 6 despite background therapy as reported and independently adjudicated (clinical score ≥ 4, excluding lupus headache and/or organic brain syndrome) at Screening:
If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
Score must be re-confirmed at the Baseline visit.
Physician's Global Assessment (PhGA) ≥ 1 during screening period.
Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (≤ 20 mg), azathioprine (≤ 150 mg), mycophenolate (\<2 g), leflunomide (≤ 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (≤ 20 mg).
No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.

Criterios de exclusión

\- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.

Intervenciones

drug

Elsubrutinib

Capsule; Oral

drug

Placebo for elsubrutinib

Capsule; Oral

drug

Upadacitinib

Film-coated tablet; Oral

drug

Placebo for upadacitinib

Film-coated tablet; Oral

Ubicaciones

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 221685

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Hospital Interzonal General de Agudos General Jose de San Martin /ID# 211679

La Plata, Buenos Aires, Argentina

CER Instituto Medico /ID# 222757

Quilmes, Buenos Aires, Argentina

Aprillus Asistencia e Investigacion /ID# 211630

Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, Argentina

Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 211634

Rosario, Santa Fe Province, Argentina

Instituto CAICI S.R.L /ID# 211633

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Medicas Tucuman /ID# 212714

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones Clinicas Tucuman /ID# 211942

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Cordoba /ID# 212200

Córdoba, Argentina

Patrocinadores

PrincipalAbbVie

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 2 Study to Investigate the Safety and Efficacy of... | EligiMed