A Study of ALPN-101 in Active Lupus

Phase 1

• Conditions: Systemic lupus erythematosus (SLE); MedDRA version: 21.1Level: PTClassification code 10042946Term: Systemic lupus erythematosus rashSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.1Level: LLTClassification code 10042948Term: Systemic lupus erythematosus syndrome aggravatedSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.1Level: LLTClassification code 10042947Term: Systemic lupus erythematosus syndSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: LLTClassification code 10029142Term: Nephritis systemic lupus erythematosusSystem Organ Class: 100000004857; MedDRA version: 20.1Level: PTClassification code 10067659Term: Systemic lupus erythematosus disease activity index abnormalSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 20.1Level: PTClassification code 10067657Term: Systemic lupus erythematosus disease activity index increasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: PTClassification code 10067658Term: Systemic lupus erythematosus disease activity index decreasedSystem Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2020-004047-86-HU
• Lead Sponsor: Alpine Immune Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-23
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

•Written informed consent
•Age 18 to 65
•Diagnosis of lupus for = 6 months prior to Screening
•Positive anti-nuclear antibodies (ANA) and/or elevated anti-double-stranded DNA (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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of ALPN-101 compared to placebo in subjects with moderate to severe active SLE<br>;Secondary Objective: • To evaluate the efficacy of ALPN-101 in subjects with active SLE<br>• To assess the pharmacokinetics (PK) of ALPN-101 in active SLE<br>• To assess the incidence of anti-drug antibodies (ADA) against ALPN-101<br>;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