Rozanolixizumab
- Generic Name
- Rozanolixizumab
- Brand Names
- Rystiggo
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1584645-37-3
- Unique Ingredient Identifier
- P7186074QC
- Background
Rozanolixizumab is a humanized high-affinity anti-human neonatal Fc receptor (FcRn) monoclonal antibody (IgG4P) targeting the immunoglobulin G (IgG). Rozonolixizumab itself is an IgG4P, an inactive isotype, to reduce the likelihood of unwanted chain exchange. It is investigated for use in autoimmune and alloimmune diseases with pathologic IgG, particularly g...
- Indication
Rozanolixizumab-noli is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
- Associated Conditions
- Generalized Myasthenia Gravis
- Associated Therapies
- -
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- First Posted Date
- 2020-10-22
- Last Posted Date
- 2024-02-05
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 43
- Registration Number
- NCT04596995
- Locations
- 🇺🇸
Tp0004 50243, Boston, Massachusetts, United States
🇨🇳Tp0004 20185, Jinan, China
🇭🇺Tp0004 40202, Győr, Hungary
A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- Conditions
- Interventions
- First Posted Date
- 2020-01-13
- Last Posted Date
- 2023-08-08
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 30
- Registration Number
- NCT04224688
- Locations
- 🇷🇺
Tp0006 20053, Saint Petersburg, Russian Federation
🇺🇦Tp0006 20061, Cherkasy, Ukraine
🇺🇦Tp0006 20064, Kyiv, Ukraine
A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
- Conditions
- Interventions
- First Posted Date
- 2019-12-16
- Last Posted Date
- 2023-08-08
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 33
- Registration Number
- NCT04200456
- Locations
- 🇺🇦
Tp0003 20062, Ivano-frankivsk, Ukraine
🇺🇦Tp0003 20100, Zaporizhzhia, Ukraine
🇲🇩Tp0003 20051, Chisinau, Moldova, Republic of
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
- First Posted Date
- 2019-10-14
- Last Posted Date
- 2023-09-05
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 71
- Registration Number
- NCT04124965
- Locations
- 🇺🇸
Mg0004 50088, Washington, District of Columbia, United States
🇨🇦Mg0004 50070, Québec, Canada
🇺🇸Mg0004 50096, Philadelphia, Pennsylvania, United States
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Conditions
- Interventions
- First Posted Date
- 2019-08-09
- Last Posted Date
- 2022-11-03
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 21
- Registration Number
- NCT04051944
- Locations
- 🇺🇸
Cidp04 50080, Durham, North Carolina, United States
🇺🇸Cidp04 50075, Augusta, Georgia, United States
🇬🇧Cidp04 40167, Sheffield, United Kingdom
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
- Conditions
- Interventions
- First Posted Date
- 2019-06-03
- Last Posted Date
- 2024-10-21
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 200
- Registration Number
- NCT03971422
- Locations
- 🇺🇸
Mg0003 50092, Orange, California, United States
🇺🇸Mg0003 50105, Saint Louis, Missouri, United States
🇮🇹Mg0003 40149, Lazio, Italy
A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Conditions
- Interventions
- First Posted Date
- 2019-03-04
- Last Posted Date
- 2023-08-01
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- Target Recruit Count
- 34
- Registration Number
- NCT03861481
- Locations
- 🇳🇱
Cidp01 601, Amsterdam, Netherlands
🇪🇸Cidp01 701, Barcelona, Spain
🇪🇸Cidp01 702, Barcelona, Spain
A Study to Evaluate Safety and Tolerability of Single Ascending Doses of Rozanolixizumab Administered by Subcutaneous Infusion in Healthy Japanese, Chinese and Caucasian Study Participants
- First Posted Date
- 2019-03-01
- Last Posted Date
- 2021-09-16
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- Target Recruit Count
- 65
- Registration Number
- NCT03859219
- Locations
- 🇬🇧
UP0060 1, London, United Kingdom
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
- First Posted Date
- 2017-02-14
- Last Posted Date
- 2021-08-03
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- Target Recruit Count
- 43
- Registration Number
- NCT03052751
- Locations
- 🇧🇪
Mg0002 102, Bruxelles, Belgium
🇧🇪Mg0002 103, Gent, Belgium
🇧🇪Mg0002 101, Leuven, Belgium
Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
- First Posted Date
- 2016-03-24
- Last Posted Date
- 2024-01-29
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 66
- Registration Number
- NCT02718716
- Locations
- 🇲🇩
Tp0001 601, Chisinau, Moldova, Republic of
🇧🇬Tp0001 1301, Sofia, Bulgaria
🇵🇱Tp0001 703, Gdańsk, Poland
Drug Development Updates
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