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Monoclonal Antibodies

Rituximab for Eye inflammation

Phase 1 & 2
Waitlist Available
Led By Craig A Elmets
Research Sponsored by University of Alabama at Birmingham
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 16 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Cicatricial pemphigoid is an autoimmune blistering disease which affects the skin, mucous membranes, and, in a small subset of patients, the eye. Progressive ocular disease can lead to irreversible damage and blindness. Conventional treatments include systemic steroids, dapsone, and immunosuppressive agents. These treatments, however, are not successful with all patients. Rituximab has been very effective in the treatment of other autoimmune disorders, and has recently been shown to be effective for autoimmune blistering pemphigus. We propose that it will also be effective in the treatment of cicatricial pemphigoid.

Eligible Conditions
  • Eye inflammation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With no Evidence of Further Scarring (Fosters Staging) at 16 Weeks

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038
4%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RituximabExperimental Treatment1 Intervention
The Rituximab dose is 1000 mg (1gm) given as an IV infusion every two weeks for 2 doses (Days 1 and 15).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved

Find a Location

Who is running the clinical trial?

BiogenIndustry Sponsor
645 Previous Clinical Trials
467,390 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,638 Previous Clinical Trials
2,330,620 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,360 Total Patients Enrolled
~0 spots leftby Oct 2025
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