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Monoclonal Antibodies

Rozanolixizumab for Thrombocytopenic Purpura (myOpportunITy3 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 week 53 or 55, compared to baseline
Awards & highlights

myOpportunITy3 Trial Summary

This trial will study the effects of rozanolixizumab, a potential new drug, in people with a certain medical condition. The goal is to see if it is safe and effective.

Eligible Conditions
  • Thrombocytopenic Purpura

myOpportunITy3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 53 or 55, compared to baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 53 or 55, 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
Percentage of Participants With TEAEs Leading to Permanent Withdrawal of Rozanolixizumab (ie, Study Discontinuation)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Change From Baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP-PAQ) to Week 53 or 55 Symptoms Domain Score
Percentage of Participants With Stable Clinically Meaningful Response Without Rescue Therapy at ≥70% of the Visits Over the Planned 52-week Treatment Period Starting at Week 4

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

myOpportunITy3 Trial Design

1Treatment groups
Experimental Treatment
Group I: Rozanolixizumab Treatment ArmExperimental Treatment1 Intervention
All study participants 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.
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
21,380 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,907 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are involved in this experiment?

"Unfortunately, this study is not actively recruiting patients at the moment. However, if you are looking for other trials, there are 135 studies that might be of interest to you. 4 of these trials are for Rozanolixizumab and the remaining 131 are exploring purpura, thrombocytopenic, idiopathic treatments."

Answered by AI

What is the primary goal of this research?

"The aim of this trial is to observe the occurrence of TEAEs leading to withdrawal of rozanolixizumab over a From Baseline to end of Safety Follow-Up Period (up to Week 60) time frame. Additionally, secondary outcomes including Change from Baseline in Patient Global Impression of Change (PGI-C), Change in dose and/or frequency of concomitant ITP medications (excluding corticosteroids) over time during exploratory dosing, and Change in dose and/or frequency of concomitant ITP medications (excluding corticosteroids) over time during maintenance dosing"

Answered by AI

What other scientific investigations have included Rozanolixizumab?

"Out of the 4 ongoing studies for Rozanolixizumab, 3 are in Phase 3. The distribution of these trials is fairly widespread, with 197 locations running them. However, many of these trials tend to be clustered around Tbilsi, Texas."

Answered by AI

Has Rozanolixizumab been cleared for use by the FDA?

"Rozanolixizumab's safety is well-documented, as this drug has progressed to Phase 3 clinical trials. This means that not only does efficacy data exist, but there are also multiple rounds of data attesting to Rozanolixizumab's safety."

Answered by AI

What makes this experiment unique in comparison to others?

"Trials for Rozanolixizumab started in 2020. The first study, conducted by UCB Biopharma SRL, had 43 participants. After this initial Phase 3 trial, the drug was approved and there are now 4 live trials taking place in 26 countries and 21 cities."

Answered by AI

Are recruitment efforts for this trial ongoing at the moment?

"The clinical trial in question is not currently recruiting patients. Though, it's worth noting that there are many other trials (139 to be exact) that are still enrolling individuals."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
2021. "A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04596995.
~10 spots leftby Apr 2025
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