NCT01369628

Brief Summary

The sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

October 22, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

June 7, 2011

Last Update Submit

October 21, 2013

Conditions

Lupus Nephritis

Keywords

Open labelDose EscalatingPhase Ib

Outcome Measures

Primary Outcomes (3)

  • The nature (preferred terms) and incidence of AEs

    Frequency tables summarizing the observed number of AEs by System Organ Class (SOC) and preferred term will be presented per regimen.

    12 weeks

  • Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease

    Percentages of subjects fulfilling the criteria (prespecified in the protocol) for an atacicept dose modification due to a decrease in IgG will be presented.

    12 weeks

  • The frequency and severity of laboratory abnormalities

    The incidence of subjects given each atacicept regimen who have shifts from Baseline in serum creatinine, serum albumin, urinary protein, or Hematology test (counts of white blood cells, neutrophils, lymphocytes, platelets) of at least 2 grades will be presented. Grading will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 toxicity grading, using the worst grade post-baseline during the 12-week treatment period.

    12 weeks

Secondary Outcomes (3)

  • The nature (preferred terms) and incidence of AEs

    36 weeks

  • Proportion of subjects fulfilling criteria for an Atacicept dose modification due to an IgG decrease

    36 weeks

  • The frequency and severity of laboratory abnormalities

    36 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

1 arm with the 3 following dose regimens: 1. Regimen 1: Atacicept 25 mg weekly for 12 weeks 2. Regimen 2: Atacicept 75 mg weekly for 12 weeks 3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Drug: Atacicept

Interventions

AtaciceptDRUG

1. Regimen 1: Atacicept 25 mg weekly for 12 weeks 2. Regimen 2: Atacicept 75 mg weekly for 12 weeks 3. Regimen 3: Atacicept 150 mg weekly for 12 weeks

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, ≥ 18 years of age, who provide written informed consent
  • Subjects must have a diagnosis of SLE satisfying ≥ 4 of 11 ACR criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class III (A or A/C), IV (A or A/C), V, or concomitant III/V or IV/V LN as defined by the International Society of Nephrology/Renal Pathology Society (ISN/RPS).
  • Subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ANA) (HEp-2 ANA ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) (≥ 30 IU/mL) at screening.
  • Subjects must have started induction therapy for LN at least 5 months prior to Trial Day 1, be considered to have received continuous treatment for LN during the 5 months prior to Trial Day 1, and have received a stable dose of MMF ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to Trial Day 1.

You may not qualify if:

  • Recent changes in immunosuppressant, ACD inhibitors for ARBs
  • Use of azathioprine, cyclosporine, tacrolimus, or cyclophosphamide or other biologics within 8 weeks prior to Trial Day 1.
  • Serum IgG \< 6 g/L
  • Estimated Glomerular Filtration Rate (GFR) ≤ 30 mL/min per 1.73 m2
  • History of Demyelinating Disease
  • Significant Hematuria and/or Proteinuria due to a reason(s) other than LN. Evaluation should be done according to the local standard of care
  • Breast feed or pregnancy
  • Legal Incapacity or limited legal capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EMD Serono Inc., One Technology Place

Rockland, Massachusetts, 02370, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Nephritis

Interventions

TACI receptor-IgG Fc fragment fusion protein

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 9, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Last Updated

October 22, 2013

Record last verified: 2013-10

Locations

US(1)