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Monoclonal Antibodies

Rozanolixizumab for Thrombocytopenic Purpura (myOpportunITy1 Trial)

Phase 3
Waitlist Available
Research Sponsored by UCB Biopharma SRL
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 time from starting treatment to achievement of first response of ≥50×10^9/l (up to week 25)
Awards & highlights

myOpportunITy1 Trial Summary

This trial will test the effectiveness of a new drug, rozanolixizumab, in treating ITP and assessing its safety.

Eligible Conditions
  • Thrombocytopenic Purpura

myOpportunITy1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from starting treatment to achievement of first response of ≥50×10^9/l (up to week 25)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from starting treatment to achievement of first response of ≥50×10^9/l (up to week 25) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Durable Clinically Meaningful Platelet Response of ≥50x10^9/L, for at Least 8 Out of 12 Weeks During the Last 12 Weeks
Secondary outcome measures
Change From Baseline to Week 25 in Primary Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) Symptoms Score
Cumulative Number of Weeks With Clinically Meaningful Platelet Response of ≥50×10^9/L Over the 24-week Treatment Period
Percentage of Participants With Clinically Meaningful Platelet Response of ≥50×10^9/L by Day 8
+5 more

Side effects data

From 2021 Phase 3 trial • 71 Patients • NCT04124965
29%
Headache
17%
Diarrhoea
12%
Blood immunoglobulin G decreased
12%
Nausea
10%
Vomiting
10%
Nasopharyngitis
10%
Rash
7%
Back pain
7%
Pyrexia
5%
Abdominal pain
5%
Urinary tract infection
5%
Hypogammaglobulinaemia
2%
Pericarditis
2%
Myasthenia gravis
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rozanolixizumab ~10 mg/kg
Rozanolixizumab ~7 mg/kg

myOpportunITy1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RozanolixizumabExperimental Treatment1 Intervention
Study participants randomized to this arm will receive fixed-unit doses of rozanolixizumab across body weight tiers at pre-specified time points during the Treatment Period. Doses will be adjusted based on platelet count values or medical needs.
Group II: PlaceboPlacebo Group1 Intervention
Study participants randomized to this arm receive placebo at pre-specified time points during the Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rozanolixizumab
2019
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,403 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,930 Total Patients Enrolled

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
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
2020. "A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04200456.
~6 spots leftby Apr 2025
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