Phase 2
N=183
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Lupus Erythematosus, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT01405196 ↗Enrolled (actual)
183
Serious AEs
12.0%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 — 59.9; 39.2; 40.1 Percentage of participants — p=0.076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04236921 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 |
59.9; 39.2; 40.1 | 0.076 |
| SECONDARY Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20 |
12.2; 7.1; 4.8; 26.8; 21.5; 26.3 | — |
| SECONDARY Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24 |
9.5; 7; 9.2; 23.8; 25.7; 30.2 | — |
| SECONDARY Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24 |
26.2; 21.7; 21; 26.2; 29; 30.6 | — |
| SECONDARY Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24 |
60.7; 44.9; 49.3; 100.0; 100.0; 90.2 | 0.205 |
| SECONDARY Number of Participants With Clinically Significant Laboratory Tests Results |
2; 0; 0; 0; 1; 1 | — |
| SECONDARY Number of Participants Who Discontinued Due to Adverse Events |
3; 2; 3; 3 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
34; 36; 38; 40; 4; 2 | — |
| SECONDARY Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs) |
25; 28; 25; 26; 2; 3 | — |
| SECONDARY Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 2; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Important Vital Signs Findings |
8; 3; 3; 5; 14; 14 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Serum Concentration of PF-04236921 |
26.3; 31.0; 15.2; 1297; 5640; 22780 | — |
| SECONDARY Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day) |
13.3; 20.8; 8.7; 20.0; 25.0; 8.7 | — |
| SECONDARY Percentage of Participants With Normalized Serological Activity |
— | — |
| SECONDARY Patient Global Visual Analog Scale (VAS) Scores at Baseline |
50.44; 47.70; 49.47 | — |
| SECONDARY Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24 |
-9.17; -1.54; -3.58; -3.24; -4.01; -1.24 | — |
| SECONDARY Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24 |
3.17; 1.45; -0.47; 5.00; 2.82; 7.02 | — |
| SECONDARY Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline |
39.50; 42.36; 39.94; 33.47; 34.36; 34.64 | — |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24 |
1.97; 1.45; 1.45; 1.57; 1.97; 2.05 | — |
| SECONDARY Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24 |
3.92; 4.78; 3.45; 6.53; 6.55; 2.61 | — |
| SECONDARY Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24 |
1.97; 1.45; 1.45; 1.57; 1.97; 2.05 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline |
25.91; 29.38; 25.96 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24 |
3.16; 2.77; 1.08; 4.39; 3.41; 2.44 | — |
Summary
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between ages of 18 and 75 years old at time of signing consent.
- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
- Have a unequivocally positive anti-nuclear antibody (ANA) test result.
- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.
Exclusion Criteria
- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
- Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
Data sourced from ClinicalTrials.gov (NCT01405196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.