A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Sponsor: Pfizer

Sommario: Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.


TIPOLOGIA STUDIO

Interventistico

FASE

Fase 2


TRATTAMENTO

  • Placebo
  • PF-06700841 15 mg
  • PF-06700841 30 mg
  • PF-06700841 45 mg

OBIETTIVO PRIMARIO

  • Misura: Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.
  • Tempo: Week 52
  • Descrizione:

OBIETTIVO SECONDARIO

  • Misura: Time to first severe flare in PF 06700841 treated participants relative to placebo.
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Proportion of participants achieving a reduction in prednisone (or equivalent) at Week 52.
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Proportion of participants achieving SRI-4 at Week 52 and have a sustained reduction of prednisone (or equivalent) at Week 52.
  • Tempo: Week 52
  • Descrizione:
  • Misura: Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
  • Tempo: Baseline, Week 52
  • Descrizione:
  • Misura: Number of treatment emergent adverse events (AE's)
  • Tempo: Baseline through Week 56
  • Descrizione:
  • Misura: Number of discontinuations due to AE's
  • Tempo: Baseline through Week 56
  • Descrizione:
  • Misura: Number of clinically significant abnormalities in vital signs
  • Tempo: Baseline through Week 56
  • Descrizione:
  • Misura: Number of clinically significant abnormalities in electrocardiograms
  • Tempo: Baseline through Week 56
  • Descrizione:
  • Misura: Number of clinically significant abnormalities in clinical laboratory values.
  • Tempo: Baseline through Week 56
  • Descrizione:

CRITERI DI ELIGIBILITA'

  • Criteri di inclusione e esclusione

    Inclusion Criteria: - Male and/or female subjects between ≥18 and ≤75 years of age inclusive. - Diagnosis of moderate to severe active Lupus. - Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids. Exclusion Criteria: - Active renal lupus - Severe active central nervous system (CNS) lupus - Have cancer or a history of cancer within 5 years of screening. - Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus. - Active bacterial, viral, fungal, mycobacterial or other infections - Psychiatric condition including recent or active suicidal ideation or behavior - Have active fibromyalgia/myofascial/chronic pain. - Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.


SESSO

Tutti


ETA' MINIMA

Età Minima: 18 Years
Età Massima: 75 Years


LUOGO

Azienda Ospedaliera Universitaria di Cagliari
Monserrato, 09042

Azienda Ospedale Università Padova
Padova, 35128

Fondazione IRCCS Policlinico S.Matteo
Pavia, 27100

A.O.U. Pisana
Pisa, 56126

REFERENTE PER INFORMAZIONI

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com