Systemic lupus erythematosus (SLE) MedDRA version: 21.1 Level: PT Classification code 10042946 Term: Systemic lupus erythematosus rash System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10042948 Term: Systemic lupus erythematosus syndrome aggravated Sy
Conditions
Interventions
Product Code: ALPN-101
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acazicolcept
CAS Number: 2270247-50-0
Current Sponsor code: ALPN-101
Other descriptive name: ALPN-101
Concentrati
Sponsors
Alpine Immune Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Written informed consent •Age 18 to 65 •Diagnosis of lupus for = 6 months prior to Screening •Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening •Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor •Standard lupus medications must be stable prior to Screening •Women must have a PAP smear and known HPV status within 12 months of Day 1 •All participants must use highly effective birth control if they/their partner are capable of becoming pregnant Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study •Proteinuria consistent with nephrotic syndrome •Active lupus-related neuropsychiatric disease •Drug-induced lupus •Any serious health condition that would place the subject at undue risk from the study or would confound interpretation of safety or efficacy outcomes •Recent or serious ongoing infection; risk or history of serious infection •Receipt of live vaccination within 8 weeks of Day 1, or expected to require live vaccination during the study •Unacceptable Screening laboratory results •History of new, ongoing, or recurrent malignancy = 5 years prior to Day 1, with some exceptions per-protocol •Pregnant or breastfeeding at the time of screening, or plans to become pregnant = 3 months following the last dose of study drug •Prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study •Diagnosis of, or fulfills diagnostic criteria for, fibromyalgia •Functional class IV lupus •Does not meet protocol washout periods for concomitant medications •Serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk •Ongoing participation in another therapeutic clinical trial •Known hypersensitivity to ALPN-101, components thereof, or excipients contained in the drug formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of ALPN-101 compared to placebo in subjects with moderate to severe active SLE ;Secondary Objective: • To evaluate the efficacy of ALPN-101 in subjects with active SLE • To assess the pharmacokinetics (PK) of ALPN-101 in active SLE • To assess the incidence of anti-drug antibodies (ADA) against ALPN-101 ;Primary end point(s): Safety and tolerability will be assessed by evaluating the type, frequency, severity, and seriousness of adverse events, including clinically significant changes in symptoms, physical exam findings, vital signs, laboratory tests (hematology, serum chemistries and coagulation, urinalysis), and electrocardiograms. ;Timepoint(s) of evaluation of this end point: According to protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: Efficacy endpoints will be assessed by evaluating disease activity relative to baseline and across treatment groups using the tools and assessments listed below, and derivatives calculated from them (e.g. SLE Responder Index [SRI] -4, -5, -6 response; time to and proportion with flare of SLE; others). -Global disease Activity Assessment Tools: • BILAG 2004 • SLEDAI-2K; SLEDAI-2K 30 • Physician’s Global Assessment of SLE Disease Activity (PhGA) -Organ-Specific Disease Activity Assessment Tools: • Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), with photography when appropriate • Swollen joints based on assessment of 28 joints (SJC-28) • Tender joints based on assessment of 28 joints (TJC-28) • Estimated glomerular filtration rate (eGFR) • Proteinuria assessed as urine protein to creatinine ratio (UPCR), • Urinary sediment analysis for hematuria, pyuria, and red cell casts -Patient Reported Outcomes and Quality of Life (QoL) Assessment tools: • Patient’s Global Assessment of Disease Activity (PtGA) • Short Form Health Survey-36 (SF-36) • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) (13-Item) -Clinical Biomarkers of SLE Activity: • High-sensitivity C-reactive protein (hsCRP) • Complement levels: C3, C4, CH50 • Anti-dsDNA antibodies -Corticosteroids: • Dose of oral and parenteral corticosteroids Pharmacokinetic Endpoints: Serum concentrations of ALPN-101 will be measured. Pharmacokinetic endpoints include estimates of maximum observed concentration (Cmax), area under the concentration-time curve (AUC), and trough concentration at the end of dosing intervals (Ctrough). Immunogenicity Endpoints: The presence and titer of ADA against ALPN-101 will be assessed at Baseline (prior to study drug administration on Day 1) and at intervals throughout the study. Samples confirmed positive for ADA may be explored for neutralizing (NAb) capacity. The relationship between ADA and PK will be a | — |
Countries
France, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Spain, United States
Contacts
Public ContactHansi Kumari
Parexel International
Outcome results
None listed