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AC0058TA for Lupus

Phase 1
Waitlist Available
Led By Roy Fleischmann, MD MACR
Research Sponsored by ACEA Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured on day 1, day 28, and day 84
Awards & highlights

Study Summary

This study is evaluating whether a drug may help reduce symptoms of lupus.

Eligible Conditions
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured on day 1, day 28, and day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured on day 1, day 28, and day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events
Secondary outcome measures
Maximum Plasma Concentration and Area Under the Curve
Pharmacodynamics of AC0058TA: Bruton's tyrosine kinase (BTK) occupancy (% occupancy)
Antibodies

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AC0058TAExperimental Treatment1 Intervention
AC0058TA will be administered in 25 mg capsules orally at the following doses: 50 mg QD, 100 mg QD, 200 mg QD and 100 mg BID
Group II: Placebo AC0058TAPlacebo Group1 Intervention
Placebo AC0058TA will be administered orally at the equivalent dose of investigational product
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AC0058TA
2016
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

ACEA Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
Hangzhou ACEA Pharmaceutical Research Co., Ltd.Industry Sponsor
8 Previous Clinical Trials
1,294 Total Patients Enrolled
Roy Fleischmann, MD MACRPrincipal InvestigatorMetroplex Clinical Research Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)
2018. "Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03878303.
All > Systemic Lupus Erythematosus > Lupus
~5 spots leftby Apr 2025
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