Rozanolixizumab for MOG-AD
(cosMOG Trial)
Recruiting in Palo Alto (17 mi)
+76 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: UCB Biopharma SRL
Disqualifiers: Multiple sclerosis, NMOSD, Active infection, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called rozanolixizumab to see if it can safely and effectively treat adults with a nervous system condition called MOG-AD. The medication aims to reduce harmful antibodies that cause the disease.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What makes the drug Rozanolixizumab unique for treating MOG-AD?
Research Team
UC
UCB Cares
Principal Investigator
001 844 599 2273
Eligibility Criteria
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.Inclusion Criteria
Participant must be clinically stable at the time of the Screening Visit and during the Screening Period
I am between 18 and 89 years old.
I have been diagnosed with MOG Antibody Disease.
See 1 more
Exclusion Criteria
I tested positive for aquaporin-4 antibodies.
Participant has a serum total IgG level ≤ 5.5g/L
I do not have any serious ongoing infections.
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Double-Blind Treatment
Participants receive either rozanolixizumab or placebo in a double-blind manner
up to approximately 132 weeks
Open-Label Extension
Participants receive rozanolixizumab in an open-label manner
up to 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Rozanolixizumab (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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.
Rozanolixizumab is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Rystiggo for:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
🇪🇺 Approved in European Union as Rystiggo for:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
🇯🇵 Approved in Japan as Rystiggo for:
- Generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mog001 50571Cleveland, OH
Mog001 50308Tampa, FL
Mog001 50553Washington, United States
Mog001 50568San Antonio, TX
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
UCB Biopharma SRL
Lead Sponsor
Trials
118
Patients Recruited
23,200+
Findings from Research
Researchers developed new RORγt inverse agonists that effectively inhibit the production of pro-inflammatory Th17 cytokines, which are linked to autoimmune diseases, by designing compounds with improved potency and physicochemical properties.
Two specific compounds, identified as 10 and 33, demonstrated strong pharmacological activity in both biochemical assays and a rodent model, successfully reducing IL-17 cytokine production after oral administration at a dose of 15 mg/kg.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Synthesis and Biological Evaluation of New Triazolo- and Imidazolopyridine RORγt Inverse Agonists.Hintermann, S., Guntermann, C., Mattes, H., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Discovery of Biaryl Amides as Potent, Orally Bioavailable, and CNS Penetrant RORγt Inhibitors.Wang, Y., Cai, W., Cheng, Y., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Substituted benzyloxytricyclic compounds as retinoic acid-related orphan receptor gamma t (RORγt) agonists.Harikrishnan, LS., Gill, P., Kamau, MG., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Targeting RORs nuclear receptors by novel synthetic steroidal inverse agonists for autoimmune disorders.Dal Prà, M., Carta, D., Szabadkai, G., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Discovery of orally efficacious RORγt inverse agonists. Part 2: Design, synthesis, and biological evaluation of novel tetrahydroisoquinoline derivatives.Kono, M., Oda, T., Tawada, M., et al.[2018]
References
Synthesis and Biological Evaluation of New Triazolo- and Imidazolopyridine RORγt Inverse Agonists. [2018]
Discovery of Biaryl Amides as Potent, Orally Bioavailable, and CNS Penetrant RORγt Inhibitors. [2020]
Substituted benzyloxytricyclic compounds as retinoic acid-related orphan receptor gamma t (RORγt) agonists. [2023]
Targeting RORs nuclear receptors by novel synthetic steroidal inverse agonists for autoimmune disorders. [2018]
Discovery of orally efficacious RORγt inverse agonists. Part 2: Design, synthesis, and biological evaluation of novel tetrahydroisoquinoline derivatives. [2018]