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Janus kinase (JAK) inhibitor

Tofacitinib for Lupus

Phase 1 & 2
Waitlist Available
Led By Hermine Brunner, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8 and 24 compared to baseline.
Awards & highlights

Summary

This trial will study the effects of a new drug, TOFA, on young adults with lupus. The aim is to see if it is safe and effective. The trial will be conducted at two medical centers in Ohio.

Eligible Conditions
  • Lupus
  • Cutaneous Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8 and 24 compared to baseline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8 and 24 compared to baseline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oral Clearance (CL/F) (Cohort 1 only)
Secondary outcome measures
AUCt (Cohort 1 only)
Cmax (Cohort 1 only)
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score
+4 more
Other outcome measures
Change in British Isles Lupus Activity Group (BILAG) score
Change in SKINDEX score
Change in SLE Disease Activity Index (SLEDAI) score
+2 more

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552
12%
Nasopharyngitis
1%
Anaemia
1%
Interstitial lung disease
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Immediate Release (IR)
Tofacitinib Modified Release (MR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tofacitinib ArmExperimental Treatment1 Intervention
open-label study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 3
~39970

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
816 Previous Clinical Trials
6,575,155 Total Patients Enrolled
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,757 Total Patients Enrolled
Hermine Brunner, MDPrincipal InvestigatorCincinnati Childrens Hospital Medical Center
~2 spots leftby Jul 2025
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