ALPN-101 for Lupus

Phase-Based Progress Estimates
Investigational Site (189), Phoenix, AZLupusALPN-101 - Drug
18 - 70
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Lupus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: From study Day 1 until End of Study (28 weeks)

Week 28
Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

ALPN-101 (acazicolcept)
1 of 3
1 of 3
1 of 3

Experimental Treatment

Non-Treatment Group

130 Total Participants · 3 Treatment Groups

Primary Treatment: ALPN-101 · Has Placebo Group · Phase 2

ALPN-101 (acazicolcept)
Experimental Group · 1 Intervention: ALPN-101 · Intervention Types: Drug
Experimental Group · 1 Intervention: ALPN-101 · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 1

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from study day 1 until end of study (28 weeks)

Who is running the clinical trial?

Alpine Immune Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
358 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
Rachel Peterson, MDStudy DirectorAlpine Immune Sciences, Inc.

Eligibility Criteria

Age 18 - 70 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with lupus at least 6 months before the screening.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Investigational Site (114)66.7%
Investigational Site (138)33.3%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Are individuals still being enlisted for this clinical investigation?

" 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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many individuals are being accepted into this research endeavor?

"Affirmative. The data on 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.