Trial record 105 of 151 for:
Rhuph20
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy (ALKIVIA+)
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| ClinicalTrials.gov Identifier: NCT05979441 |
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Recruitment Status :
Recruiting
First Posted : August 7, 2023
Last Update Posted : April 8, 2024
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Sponsor:
argenx
Information provided by (Responsible Party):
argenx
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Brief Summary:
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myositis Active Idiopathic Inflammatory Myopathy Dermatomyositis Polymyositis Immune-Mediated Necrotizing Myopathy Antisynthetase Syndrome | Biological: EFG PH20 SC | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy |
| Actual Study Start Date : | September 12, 2023 |
| Estimated Primary Completion Date : | September 2027 |
| Estimated Study Completion Date : | September 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Idiopathic inflammatory myopathy
| Arm | Intervention/treatment |
|---|---|
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Experimental: EFG PH20 SC
participants receiving efgartigimod PH20 SC on top of background treatment
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Biological: EFG PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
Primary Outcome Measures :
- Incidence treatment-emergent adverse events and adverse event of special interest [ Time Frame: Up to 60 weeks ]
Secondary Outcome Measures :
- Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) [ Time Frame: Up to 52 weeks ]
- Prednisone dose reduction (average monthly dose) [ Time Frame: Up to 52 weeks ]
- Proportion of participants who discontinue corticosteroids [ Time Frame: Up to 52 weeks ]
- Total improvement score (TIS) [ Time Frame: Up to 52 weeks ]measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
- Proportion of TIS responders (minimal, moderate, major) [ Time Frame: up to 52 weeks ]
- Individual core set measures (CSMs) of the TIS [ Time Frame: up to 52 weeks ]measured on a [0,100] scale. Higher scores represent improvement; zero indicates no improvement or worsening (from baseline).
- Percentage of participants with clinically inactive disease [ Time Frame: up to 52 weeks ]
- Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks [ Time Frame: up to 52 weeks ]
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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:
- Has completed trial ARGX-113-2007
- Being capable of providing signed informed consent and complying with protocol requirements
- Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product
Exclusion Criteria:
- Intention to have major surgery during the study period; or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk
- Known hypersensitivity reaction to investigational medicinal product or 1 of its excipients Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
- Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
- Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from IMP as defined by a score of "much better" or "moderately better" on the 'Clinical Global Impression of Change' and 'Patient Global
- Impression of Change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest
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): NCT05979441
Contacts
| Contact: Sabine Coppieters, MD | 857-350-4834 | Clinicaltrials@argenx.com |
Locations
| United States, California | |
| Attune Health Research, Inc | Recruiting |
| Beverly Hills, California, United States, 90039 | |
| Contact: Swamy Venuturupalli, MD 857-350-4834 clinicaltrials@argenx.com | |
| UCI Health - ALS and Neuromuscular Center - Neurology | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Tahseen Mozaffar, MD 857-350-4834 clinicaltrials@argenx.com | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Contact: Siamak Moghadam-Kia, MD 857-350-4834 clinicaltrials@argenx.com | |
| United States, Texas | |
| Austin Neuromuscular Center (National Neuromuscular Research Institute, PLLC) | Recruiting |
| Austin, Texas, United States, 78759 | |
| Contact: Yessar Hussain, MD 857-350-4834 clinicaltrials@argenx.com | |
| Nerve And Muscle Center Of Texas | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Aziz I. Shaibani, MD 857-350-4834 clinicaltrials@argenx.com | |
| Argentina | |
| Centro Medico Privado de Reumatologia | Recruiting |
| San Miguel De Tucumán, Argentina, 4000 | |
| Contact: Horacio Berman, MD 857-350-4834 clinicaltrials@argenx.com | |
| Belgium | |
| Universitair Ziekenhuis Leuven Gasthuisberg Campus | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Ellen de Langhe, MD 857-350-4834 clinicaltrials@argenx.com | |
| Bulgaria | |
| Medical Centre Artmed | Recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Contact: Mariela Geneva-Popova, MD 857-350-4834 clinicaltrials@argenx.com | |
| Denmark | |
| Copenhagen University Hospital-Rigshospitalet University Hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Louise Diederichsen, MD 857-350-4834 clinicaltrials@argenx.com | |
| Georgia | |
| Aversi Clinic | Recruiting |
| Tbilisi, Georgia, 0160 | |
| Contact: Irine Malazonia, MD 857-350-4834 clinicaltrials@argenx.com | |
| LLC MediClub Georgia | Recruiting |
| Tbilisi, Georgia, 0160 | |
| Contact: Levan Shalamberidze, MD 857-350-4834 clinicaltrials@argenx.com | |
| The First Medical Center | Recruiting |
| Tbilisi, Georgia, 0180 | |
| Contact: Tamta Kobakhidze, MD 857-350-4834 clinicaltrials@argenx.com | |
| Greece | |
| National and Kapodistrian University of Athens - Eginition Hospital | Recruiting |
| Athens, Greece, 115 28 | |
| Contact: George Papadimas, MD 857-350-4834 clinicaltrials@argenx.com | |
| Korea, Republic of | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 03080 | |
| Contact: Jun Won Park, MD 857-350-4834 clinicaltrials@argenx.com | |
| Lithuania | |
| Santaros University Clinic | Recruiting |
| Vilnius, Lithuania, 08410 | |
| Contact: Irena Butrimiene, MD 857-350-4834 clinicaltrials@argenx.com | |
Sponsors and Collaborators
argenx
Additional Information:
| Responsible Party: | argenx |
| ClinicalTrials.gov Identifier: | NCT05979441 |
| Other Study ID Numbers: |
ARGX-113-2011 |
| First Posted: | August 7, 2023 Key Record Dates |
| Last Update Posted: | April 8, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Muscular Diseases Dermatomyositis Myositis Polymyositis Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |