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Monoclonal Antibodies

Rozanolixizumab for MOG-AD (cosMOG Trial)

Phase 3

Recruiting

Research Sponsored by UCB Biopharma SRL

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent

Confirmed diagnosis of MOG-AD consistent with published diagnostic criteria for MOG-AD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

Awards & highlights

cosMOG Trial Summary

This trial will test if the drug Rozanolixizumab is effective, safe, and tolerable for people with MOG antibody-associated disease.

Who is the study for?

This trial is for adults aged 18-89 with a confirmed diagnosis of MOG-AD, who have had at least one relapse in the past year and tested positive for MOG antibodies recently. They must be stable health-wise and not have other autoimmune diseases or primary immunodeficiency.Check my eligibility

What is being tested?

The study tests Rozanolixizumab's effectiveness and safety against a placebo in treating MOG-AD. Participants will randomly receive either the actual drug or a placebo to compare outcomes.See study design

What are the potential side effects?

While specific side effects are not listed here, typical reactions may include infusion-related discomfort, potential immune system changes, allergic reactions, or general medication intolerance.

cosMOG Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 89 years old.

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I have been diagnosed with MOG Antibody Disease.

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I have had at least one MOG-AD relapse in the past year and a positive MOG antibody test.

cosMOG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), edb/ewd visit (until a confirmed relapse or up to approximately 132 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period

For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period

For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period

Secondary outcome measures

For Part A: Change from Baseline in Low-Contrast Monocular Visual Acuity (Worst Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit

For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months)

For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period

+2 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

Back pain

Pyrexia

Abdominal pain

Urinary tract infection

Hypogammaglobulinaemia

Pericarditis

Myasthenia gravis

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Rozanolixizumab ~10 mg/kg

Rozanolixizumab ~7 mg/kg

cosMOG Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Rozanolixizumab ArmExperimental Treatment1 Intervention

Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.

Group II: Placebo ArmPlacebo Group1 Intervention

Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rozanolixizumab

2019

Completed Phase 3

~560

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,332 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

44,859 Total Patients Enrolled

Media Library

Rozanolixizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05063162 — Phase 3

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Research Study Groups: Rozanolixizumab Arm, Placebo Arm

Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Clinical Trial 2023: Rozanolixizumab Highlights & Side Effects. Trial Name: NCT05063162 — Phase 3

Rozanolixizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063162 — Phase 3

Frequently Asked Questions

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

How many different areas are responsible for this research project?

"The trial locations include Mog001 50450 in Palo Alto, California, Mog001 50243 in Boston, Massachusetts, Mog001 50101 in Aurora, Colorado, and 6 other sites."

Answered by AI

Are people with the qualifying condition able to participate in this research project at this time?

"The clinical trial is recruiting patients, as seen on clinicaltrials.gov. The study was originally posted on February 2nd, 2022 and was updated on September 15th, 2022."

Answered by AI

Who does this study target as its ideal candidate?

"Eligible patients for this study should have myelin oligodendrocyte glycoprotein antibody-associated disease (mog-ad) and fall in the age bracket of 18 to 89 years old. Currently, the study is trying to recruit approximately 104 patients."

Answered by AI

Is this medication new to the market or have other research teams looked into it before?

"There are 4 ongoing clinical trials for Rozanolixizumab, with most of the research happening in Chisinau and Massachusetts. A total of 190 medical facilities are conducting research on Rozanolixizumab."

Answered by AI

Could you explain the age requirements for this particular test group?

"Eligibility criteria for this trial include being over 18 and under 89 years old."

Answered by AI

Has Rozanolixizumab been cleared by the FDA?

"There is existing clinical evidence to support the safety of Rozanolixizumab, which is why it received a score of 3."

Answered by AI

Is this a cutting-edge clinical trial?

"First appearing in 2020, Rozanolixizumab has been the focus of 4 clinical trials in the past two years. 43 patients participated in the initial study, which was sponsored by UCB Biopharma SRL. After this first study, Rozanolixizumab received Phase 3 drug approval and is now being tested in 20 cities across 25 countries."

Answered by AI

What are the desired outcomes of this clinical trial?

"The goal of this trial is to assess the incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of the investigational medicinal product (IMP) during the OLE Treatment Period. Secondary outcomes include change from Baseline in low-contrast monocular visual acuity (Least Affected Eye) measured by low-contrast Landolt C Broken Rings Chart at the EDB/EWD Visit (with confirmation at 3 months). The trial will be conducted over a Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to 132 weeks)"

Answered by AI