A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD) (cosMOG)
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| ClinicalTrials.gov Identifier: NCT05063162 |
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Recruitment Status :
Recruiting
First Posted : September 30, 2021
Last Update Posted : April 26, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD) | Drug: Rozanolixizumab Other: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | MOG001 consists of a Double-Blind (Part A) and an Open-Label Extension Study Period (Part B). |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3, Pivotal Study With an Open-Label Extension Period to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-Associated Disease (MOG-AD) |
| Actual Study Start Date : | February 2, 2022 |
| Estimated Primary Completion Date : | August 10, 2026 |
| Estimated Study Completion Date : | October 5, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Rozanolixizumab Arm
Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.
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Drug: Rozanolixizumab
Participants will receive pre-specified doses of rozanolixizumab. Other Name: UCB7665 |
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Placebo Comparator: Placebo Arm
Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.
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Other: Placebo
Participants will receive placebo. Other Name: PBO |
- For Part A: Time from randomization to first independently centrally adjudicated relapse (TTFR) during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks) ]
The TTFR (days) will be defined as the interval between the date of randomization and the first date of the objective relapse.
During the Double Blind (DB) Treatment Period (Part A); EDB/EWD = End of Double-Blind/Early Withdrawal Visit
- For Part B: Incidence of treatment-emergent adverse events (TEAEs) during OLE Treatment Period [ Time Frame: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
Open-Label Extension (OLE) Treatment Period (Part B); EOS/EWD = End of Study/Early Withdrawal Visit.
- For Part B: Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period [ Time Frame: OLE Treatment Period (OLE Week 1) to EOS/EWD Visit (up to OLE Week 52) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs leading to discontinuation of the study are reported.
During Part B.
- 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 [ Time Frame: From Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks) ]
Visual acuity is a measurement of the capacity for visual discrimination of fine details. Visual acuity tests are used to determine the smallest characters that can be read on a standardized chart. The Landolt C Broken Ring Chart uses standardized incomplete rings or "C", which are positioned in any direction in the chart (up, down, left, right, and 45 degree positions in between). The participant has to be able to indicate where the break of the "C" is located, by describing the position or by giving gesture.
During Part A.
- For Part A: Disability as assessed by Expanded Disability Status Scale (EDSS) scores at the EDB/EWD Visit (with confirmation at 3 months) [ Time Frame: Baseline (Week 1), EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks) ]
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death) in half-point increments with half steps from 1.0 to 9.5. The higher the value the higher is the level of impairment and disability.
During Part A.
- For Part A: Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks) ]
The total number of MOG-AD related hospitalizations from Baseline through EDB/EWD Visit.
During Part A.
- For Part A: Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (until a confirmed relapse or up to approximately 132 weeks) ]
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP.
During Part A.
- For Part B: Independently centrally adjudicated annualized relapse rate (ARR) during the DB and OLE Treatment Period [ Time Frame: Baseline (Week 1) to EOS/EWD Visit (up to OLE Week 52) ]An ARR will be calculated for each participant prior to randomization into the Double-Blind Treatment Period (based on available historical data), and 2 ARRs after randomization to study treatment: first for relapses occurring during the Double-Blind Treatment Period and the second for relapses occurring during the OLE Treatment Period. The relapse episodes for each participant will be recorded throughout the entire study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 months and a documented positive serum MOG Ab test using a cell-based assay (CBA) within 6 months prior to randomization
- Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
Exclusion Criteria:
- Participant has been diagnosed with a neurological autoimmune disease (including multiple sclerosis (MS) and aquaporin-4 positive neuromyelitis optica spectrum disorder (NMOSD)), or a systemic autoimmune disease that in the opinion of the investigator can interfere with the safety of the participant
- Participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator, including participants with a serious infection within 6 weeks prior to the first dose of the investigational medicinal product (IMP)
- Participant has a current or medical history of primary immunodeficiency
- Participant tests positive for aquaporin-4 antibodies at Screening
- Participant has a serum total IgG level ≤ 5.5g/L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05063162
| Contact: UCB Cares | 1-844-599-2273 (USA) | UCBCares@ucb.com | |
| Contact: UCB Cares | 001 844 599 2273 | UCBCares@ucb.com |
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| Study Director: | UCB Cares | 001 844 599 2273 |
| Responsible Party: | UCB Biopharma SRL |
| ClinicalTrials.gov Identifier: | NCT05063162 |
| Other Study ID Numbers: |
MOG001 2021-000352-19 ( EudraCT Number ) |
| First Posted: | September 30, 2021 Key Record Dates |
| Last Update Posted: | April 26, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. |
| Access Criteria: | Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. |
| URL: | http://www.Vivli.org |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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MOG MOGAD Rozanolixizumab Myelin oligodendrocyte glycoprotein Myelin oligodendrocyte glycoprotein antibody-associated disease |
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Rozanolixizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |