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Immunomodulator

ALPN-101 for Lupus (Synergy Trial)

Phase 2
Waitlist Available
Research Sponsored by Alpine Immune Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active lupus at Screening and Baseline, as defined per-protocol and confirmed by the study's medical monitor, including a SLEDAI score at Screening of ≥ 6 and a clinical score at Baseline of ≥ 4
Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test
Must not have
Recent or serious ongoing infection; risk or history of serious infection
Diagnosis of, or fulfills diagnostic criteria for fibromyalgia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study day 1 until end of study (28 weeks)

Summary

This trial is studying a new drug to treat lupus. The drug will be tested for safety, how well it works, and what side effects it may cause.

Who is the study for?
Adults aged 18-65 with moderate to severe active systemic lupus erythematosus (SLE) can join this trial. They must have had SLE for at least 6 months, show certain antibodies in their blood tests, and have stable lupus medications before screening. Active disease is required as shown by specific scores on the SLEDAI test. Participants or their partners capable of pregnancy must use effective birth control.
What is being tested?
The study is testing ALPN-101 (acazicolcept), a potential new treatment for SLE against a placebo. It's a Phase 2 trial that aims to assess how safe and effective ALPN-101 is, how it affects the immune system, its side effects, and how the body processes it.
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to the immune system due to ALPN-101 since it targets inflammation pathways involved in lupus. Side effects could include infusion-related reactions and possible impacts on infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lupus is active with a SLEDAI score of 6 or more and a clinical score of 4 or more.
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I have positive ANA or high levels of anti-dsDNA or anti-Smith antibodies.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a current serious infection or a history of serious infections.
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I have been diagnosed with fibromyalgia.
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My lupus is severe and requires immediate strong treatment, making me unsuitable for a study with possible placebo use.
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I have active brain or nerve symptoms due to lupus.
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I have another autoimmune disease that might affect this study's results.
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My lupus is severe and might need more treatment soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study day 1 until end of study (28 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study day 1 until end of study (28 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALPN-101 (acazicolcept)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALPN-101
2019
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Alpine Immune Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
456 Total Patients Enrolled
Jan Hillson, MDStudy DirectorAlpine Immune Sciences, Inc.
3 Previous Clinical Trials
615 Total Patients Enrolled
Pille Harrison, MDStudy DirectorAlpine Immune Sciences, Inc.
5 Previous Clinical Trials
319 Total Patients Enrolled

Media Library

ALPN-101 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04835441 — Phase 2
Lupus Research Study Groups: ALPN-101 (acazicolcept), Placebo
Lupus Clinical Trial 2023: ALPN-101 Highlights & Side Effects. Trial Name: NCT04835441 — Phase 2
ALPN-101 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835441 — Phase 2
~30 spots leftby Nov 2025
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