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.
- Lupus
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: From study Day 1 until End of Study (28 weeks)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
ALPN-101 (acazicolcept)
1 of 3
ALPN-101
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
130 Total Participants · 3 Treatment Groups
Primary Treatment: ALPN-101 · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Georgia | 66.7% |
| Michigan | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
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 criteria | 100.0% |
Frequently Asked Questions
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)." - Anonymous Online Contributor
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
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
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
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
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." - Anonymous Online Contributor