Trial record 1 of 1 for:
NCT03052751
Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03052751 |
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Recruitment Status :
Completed
First Posted : February 14, 2017
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
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Sponsor:
UCB Biopharma S.P.R.L.
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )
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Brief Summary:
The purpose of the study is to evaluate the clinical efficacy of UCB7665 as a chronic-intermittent treatment in subjects with generalized myasthenia gravis (MG) who are classified as moderate to severe.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myasthenia Gravis | Drug: UCB7665 Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | This is an Investigator- and Subject-Blind study. |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis |
| Actual Study Start Date : | May 15, 2017 |
| Actual Primary Completion Date : | May 31, 2018 |
| Actual Study Completion Date : | August 6, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Myasthenia gravis
MedlinePlus related topics:
Myasthenia Gravis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dosage Regimen 1
Subjects randomized in dosage regimen 1 will receive 3 doses of UCB7655 (dose 1) in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
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Drug: UCB7665
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)
Other Name: Rozanolixizumab |
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Experimental: Dosage Regimen 2
Subjects randomized in dosage regimen 2 will receive 3 doses of placebo in dosing period 1 and will then be re-randomized into dosing period 2 to receive 3 doses of UCB7665 (dose 1 or dose 2).
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Drug: UCB7665
UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)
Other Name: Rozanolixizumab Other: Placebo Placebo will be administered in period 1 of dosage regimen 2. |
Primary Outcome Measures :
- Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score to Visit 9 [ Time Frame: From Baseline to Visit 9 (up to Day 29) ]The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
Secondary Outcome Measures :
- Change From Baseline in Myasthenia Gravis-Composite Score to Visit 9 [ Time Frame: From Baseline to Visit 9 (up to Day 29) ]The total Myasthenia Gravis (MG)-composite score was obtained by summing the responses to each individual item (10 items; Grade: 0-9 depending on item). The score ranges from 0 to 50, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
- Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MGADL) Score to Visit 9 [ Time Frame: From Baseline to Visit 9 (up to Day 29) ]The total MGDAL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3). The score ranges from 0 to 24, with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has a well-documented diagnosis of myasthenia gravis (MG) at Visit 1 (Screening), based on subject history and supported by previous evaluations
- Subject would currently be considered for treatment with immunological therapy (immunoglobulin/plasma exchange (IVIG/PLEX)) by the investigator
- Subject has a well-documented record of autoantibodies against anti-acetylcholine receptor (Anti-AChR) or anti-muscle specific kinase (Anti-MuSK) prior to Screening
- Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable will use a highly effective method of birth control
- Male subjects must be willing to use a method of contraception
Exclusion Criteria:
- Subject has previously received treatment in this study or subject has previously been exposed to UCB7665
- Subject has participated in another study of an investigational medicinal product (IMP; or a medical device) within the previous 30 days of Screening or is currently participating in another study of an investigational medicinal product (IMP; or a medical device)
- Subject has a known hypersensitivity to any components of the IMP
- Subject has a history of hyperprolinemia, since L-proline is a constituent of the UCB7665 IMP
- Subjects with Myasthenia Gravis (MG) only affecting the ocular muscles
- Subjects with severe weakness affecting oropharyngeal or respiratory muscles, or who have myasthenic crisis at Screening or impending crisis
- Subject has quantitative myasthenia gravis (QMG) score of <11 at Baseline
- Subject has a serum total immunoglobulin G (IgG) level <= 6g/L at Screening
- Absolute neutrophil count <1500 cells/mm^3
- Subject has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
- Subject has any laboratory abnormality that, in the opinion of the investigator, is clinically significant, has not resolved at randomization, and could jeopardize or would compromise the subject's ability to participate in this study
- Subject has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of IMP
- Subject has received any experimental biological agent within or outside of a clinical study in the past 3 months or within 5 half-lives prior to Baseline (whichever is longer)
Information from the National Library of Medicine
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): NCT03052751
Locations
Show 20 study locations
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
| Study Director: | UCB Cares | +1 877 822 9493 (UCB) |
Study Documents (Full-Text)
Documents provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Documents provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Study Protocol [PDF] September 15, 2017
Statistical Analysis Plan [PDF] June 20, 2018
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Biopharma S.P.R.L. |
| ClinicalTrials.gov Identifier: | NCT03052751 |
| Other Study ID Numbers: |
MG0002 2016-002698-36 ( EudraCT Number ) |
| First Posted: | February 14, 2017 Key Record Dates |
| Results First Posted: | August 3, 2021 |
| Last Update Posted: | August 3, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
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UCB7665 Myasthenia Gravis |
Additional relevant MeSH terms:
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Myasthenia Gravis Muscle Weakness Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Pathologic Processes Paraneoplastic Syndromes, Nervous System Nervous System Neoplasms Neoplasms by Site Neoplasms |
Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases Immune System Diseases Rozanolixizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |