History of Changes for Study: NCT05063162

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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Study Record Versions

Version	Submitted Date	Changes
1	September 21, 2021	None (earliest Version on record)
2	November 23, 2021	Study Status
3	January 17, 2022	Study Status
4	February 10, 2022	Recruitment Status, Study Status, Contacts/Locations and Oversight
5	March 1, 2022	Study Status and Contacts/Locations
6	March 24, 2022	Contacts/Locations and Study Status
7	April 6, 2022	Contacts/Locations, Outcome Measures, Study Status and Oversight
8	April 21, 2022	Contacts/Locations and Study Status
9	May 5, 2022	Study Status and Contacts/Locations
10	May 19, 2022	Contacts/Locations and Study Status
11	June 9, 2022	Contacts/Locations and Study Status
12	July 7, 2022	Study Status and Contacts/Locations
13	August 15, 2022	Study Status and Contacts/Locations
14	September 15, 2022	Study Status and Contacts/Locations
15	November 7, 2022	Outcome Measures, Contacts/Locations, Study Status and Eligibility
16	November 10, 2022	Study Status and Contacts/Locations
17	November 24, 2022	Contacts/Locations and Study Status
18	December 8, 2022	Study Status and Contacts/Locations
19	January 5, 2023	Study Status and Contacts/Locations
20	February 2, 2023	Study Status and Contacts/Locations
21	February 16, 2023	Contacts/Locations and Study Status
22	April 12, 2023	Study Status, Outcome Measures, Eligibility, Study Design and Oversight
23	April 27, 2023	Contacts/Locations, Oversight and Study Status
24	May 9, 2023	Study Status and Oversight
25	May 11, 2023	Contacts/Locations and Study Status
26	August 7, 2023	Study Status and Eligibility
27	August 17, 2023	Contacts/Locations and Study Status
28	September 28, 2023	Study Status and Contacts/Locations
29	October 12, 2023	Study Status and Contacts/Locations
30	December 4, 2023	Study Status and Conditions
31	December 7, 2023	Contacts/Locations and Study Status
32	December 19, 2023	Contacts/Locations and Study Status
33	February 1, 2024	Contacts/Locations and Study Status
34	February 15, 2024	Study Status and Contacts/Locations
35	March 14, 2024	Study Status and Contacts/Locations
36	March 28, 2024	Contacts/Locations and Study Status
37	April 11, 2024	Study Status and Contacts/Locations
38	April 25, 2024	Contacts/Locations and Study Status
39	May 9, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	MOG001
Brief Title:	A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD) (cosMOG)
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)
Secondary IDs:	2021-000352-19 [EudraCT Number]

Study Status


Record Verification:	September 2021
Overall Status:	Not yet recruiting
Study Start:	November 5, 2021
Primary Completion:	July 23, 2025 [Anticipated]
Study Completion:	July 23, 2025 [Anticipated]

First Submitted:	September 21, 2021
First Submitted that Met QC Criteria:	September 21, 2021
First Posted:	September 30, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	September 21, 2021
Last Update Posted:	September 30, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	UCB Biopharma SRL
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	The purpose of the study is to evalute the efficacy, safety and tolerability of rozanolixizumab for treatment of adult participants with myelin oligodendrocyte glycoprotein (MOG) antibody-associated disease (MOG-AD).
Detailed Description:

Conditions


Conditions:	Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOG-AD)
Keywords:	MOG MOG-AD Rozanolixizumab Myelin oligodendrocyte glycoprotein Myelin oligodendrocyte glycoprotein antibody-associated disease

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	104 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Rozanolixizumab Arm Participants randomized into this arm will receive rozanolixizumab at pre-specified timepoints.	Drug: Rozanolixizumab Pharmaceutical form: Solution for infusion Route of administration: subcutaneous infusion Participants will receive pre-specified doses of rozanolixizumab. Other Names: UCB7665
Placebo Comparator: Placebo Arm Participants randomized into this arm will receive placebo at pre-specified timepoints to maintain the blinding.	Placebo Pharmaceutical form: Solution for infusion Route of administration: subcutaneous infusion Participants will receive placebo. Other Names: PBO

Outcome Measures


Primary Outcome Measures:
1.	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 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
2.	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.
3.	Incidence of treatment-emergent adverse events (TEAEs) leading to permanent withdrawal of investigational medicinal product (IMP) during OLE Treatment Period [ Time Frame: OLE 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.
Secondary Outcome Measures:
1.	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 (up to 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.
2.	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 (up to 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.
3.	Number of MOG-AD related inpatient hospitalizations during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (up to 132 weeks) ] The total number of inpatient hospitalizations from Baseline through EDB/EWD Visit. During Part A.
4.	Independently centrally adjudicated annualized relapse rate (ARR) during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (up to 132 weeks) ] An on-study ARR will be calculated for each participant based on the confirmed adjudicated relapse(s) observed in the Double-Blind Treatment Period. During Part A.
5.	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) [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (up to 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.
6.	Incidence of treatment-emergent adverse events (TEAEs) during the DB Treatment Period [ Time Frame: Baseline (Week 1) to EDB/EWD Visit (up to 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.
7.	Independently centrally adjudicated annualized relape 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. During Part A and Part B.

Eligibility


Minimum Age:	18 Years
Maximum Age:	89 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent Participant must have a history of myelin oligodendrocyte glycoprotein antibody-associated disease (MOG-AD) with any of the following clinical presentations: Optic neuritis (single, recurrent, or simultaneous bilateral) Transverse myelitis (including Longitudinally extensive spinal cord lesion (LETM)) Acute disseminated encephalomyelitis or MOG antibody-associated encephalitis, brain stem encephalitis Combined presentations Positivity for serum MOG-Immunglobulin G (IgG) antibodies using cell-based assay at Screening Participant has history of relapsing MOG-AD with at least 1 documented relapse over the last 12 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 relevant active infection (eg, sepsis, pneumonia, or abscess), or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP) Participant has a current or medical history of primary immunodeficiency Participant has a current or medical history of IgA deficiency Participant tests positive for aquaporin-4 antibodies at screening Participant has a serum total IgG level ≤ 5.5g/L

Contacts/Locations


Central Contact Person:	UCB Cares Telephone: 001844599 Ext. 2273 Email: UCBCares@ucb.com
Study Officials:	UCB Cares Study Director 001 844 599 2273 (UCB)
Locations:

IPDSharing


Plan to Share IPD:	Yes 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 Information: 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

References


Links:
Available IPD/Information: