Atacicept Dose for Lupus Nephritis (LN)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lupus Nephritis (LN)+2 More
Atacicept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.

Eligible Conditions
  • Lupus Nephritis (LN)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Weeks 52 and 104

Week 104
Renal Response at Week 104
Time to Death or Renal-Related Event
Week 52
Renal Response
Time to UPCR of≤0.5 mg/mg
Weeks 52 and 104
Renal Response with alternative success criteria

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Atacicept 25 mg
18%Headache
8%Nausea
6%Urinary tract infection
6%Constipation
6%Diarrhoea
5%Hypertension
5%Nasopharyngitis
5%Upper respiratory tract infection
3%Rheumatoid arthritis
2%Gamma-glutamyltransferase increased
2%Upper limb fracture
2%Intestinal obstruction
2%Pelvic fracture
2%Iron deficiency anaemia
2%Femur fracture
2%Humerus fracture
2%Relapsing fever
2%Diverticular perforation
2%Fibrin D dimer increased
2%Hyperthyroidism
2%Anaemia
2%Non-cardiac chest pain
2%Pyrexia
2%Drug hypersensitivity
2%Fallopian tube cyst
This histogram enumerates side effects from a completed 2009 Phase 2 trial (NCT00430495) in the Atacicept 25 mg ARM group. Side effects include: Headache with 18%, Nausea with 8%, Urinary tract infection with 6%, Constipation with 6%, Diarrhoea with 6%.

Trial Design

2 Treatment Groups

Atacicept Dose
1 of 2
Placebo to match Atacicept
1 of 2

Experimental Treatment

Non-Treatment Group

360 Total Participants · 2 Treatment Groups

Primary Treatment: Atacicept Dose · Has Placebo Group · Phase 3

Atacicept Dose
Drug
Experimental Group · 1 Intervention: Atacicept · Intervention Types: Drug
Placebo to match Atacicept
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atacicept
2006
Completed Phase 2
~600

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 52 and 104

Who is running the clinical trial?

Vera Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
146 Total Patients Enrolled
Joanne CurleyStudy DirectorChief Development Officer
1 Previous Clinical Trials
116 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female at least 18 years of age at time of signing consent.
You must have the ability to understand and sign and date a written informed consent form.
You have a biopsy-proven active lymph node.
The diagnosis must be confirmed by histopathology or by immunohistochemistry.
You are willing to take oral MMF for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.