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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study day 1 until end of study (28 weeks)
Awards & highlights

Synergy Trial 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.Check my eligibility
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.See study design
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.

Synergy Trial Eligibility Criteria

Inclusion Criteria

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

Synergy Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events

Synergy 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being enlisted for this clinical investigation?

"Clinicaltrials.gov specifies that this clinical trial, which was initially advertised on June 22nd 2021, is still open for recruitment and has recently been revised (October 14th 2022)."

Answered by AI

Which individuals meet the prerequisites for joining this trial?

"This clinical study is seeking 130 individuals, 18-65 years of age and with a systemic lupus erythematosus diagnosis. Prospective participants should meet certain criteria as determined by the medical monitor; these include an active lupus status confirmed through SLEDAI score ≥ 6 at screening and clinical score ≥ 4 at baseline. Moreover, if applicable, all participants must utilize highly efficacious contraceptive methods to prevent potential pregnancy."

Answered by AI

How secure is the usage of ALPN-101 for humans?

"After assessing ALPN-101, our team has graded its safety as a 2 due to the lack of evidence regarding efficacy despite some existing data that demonstrates safety."

Answered by AI

How many medical centers are currently performing this experiment?

"Patients at Investigational Site (133) in Plantation, Florida, Investigational Site (131) in Port Orange, Texas, and Investigational Site (162) in San Antonio are being accepted by this clinical trial along with 37 additional sites."

Answered by AI

Are participants of this trial required to be over 18 years of age?

"According to the criteria for enrolment, individuals older than 18 years old and younger than 65 can take part in this trial."

Answered by AI

How many individuals are being accepted into this research endeavor?

"Affirmative. The data on clinicaltrials.gov attests to the fact that this medical trial, which was initially posted in June of 2021, is actively recruiting patients from 37 different locations with a total of 130 participants being sought after."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Georgia
How old are they?
18 - 65
What site did they apply to?
Investigational Site (138)
Investigational Site (104)
Investigational Site (114)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus
2021. "ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04835441.
All > Systemic Lupus Erythematosus > Lupus
~19 spots leftby Nov 2024
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