A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) (ADHERE+)
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ClinicalTrials.gov Identifier: NCT04280718 |
Recruitment Status :
Active, not recruiting
First Posted : February 21, 2020
Last Update Posted : August 4, 2023
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This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: Efgartigimod PH20 SC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 226 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
Actual Study Start Date : | September 18, 2020 |
Estimated Primary Completion Date : | March 1, 2027 |
Estimated Study Completion Date : | March 1, 2027 |
Arm | Intervention/treatment |
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Experimental: efgartigimod PH20 SC
Patients treated with efgartigimod PH20 SC
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Biological: Efgartigimod PH20 SC
Subcutaneous administration of efgartigimod
Other Name: ARGX-113 |
- Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time of the adjusted INCAT score [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time of the MRC Sum score [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time of I-RODS disability scores [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time of mean grip strength [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time of TUG score [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Percentage of patients without clinical deterioration over time, defined by adjusted INCAT deterioration ≥1 point compared to baseline. [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Percentage of patients with titers of binding antibodies towards efgartigimod and the presence of neutralizing antibodies against efgartigimod. [ Time Frame: Up to 51 weeks ]
- Efgartigimod serum concentrations [ Time Frame: Up to 51 weeks ]
- Changes from baseline over time of serum IgG levels (total) [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time in EQ-5D-5L [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time in BPI SF [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time in TSQM-9 [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time in RT-FSS [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Change from baseline over time in HADS [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Percentage of patients performing self-administration over time [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
- Percentage of patients with treatment administered by caregiver over time. [ Time Frame: Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to understand the requirements of the trial, provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits) of this trial.
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Male or female patient with one of the following options:
- Have completed the Week-48 visit of Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC; or
- Have deteriorated during Stage B of the ARGX-113-1802 trial and are considered to be eligible for treatment with efgartigimod PH20 SC, or
- Have been offered the participation in the OLE trial due to early termination of the ARGX-113-1802 trial (because sufficient events for the primary endpoint analysis of the that trial have been reached and it is stopped) and are considered to be eligible for treatment with efgartigimod PH20 SC treatment; or
- Have completed the Week-48 visit of the previous cycle of the OLE trial and are considered to be eligible to continue with efgartigimod PH20 SC treatment.
- Women of childbearing potential who have a negative urine pregnancy test at baseline before IMP administration.
- Women of childbearing potential must use an acceptable method of contraception from signing the ICF until the date of the last administration of IMP.
Exclusion Criteria:
- Week-48/ED visit in the ARGX-113-1802 trial or the Week-48 visit of the previous OLE participation occurred more than 14 days prior to SD1 of the OLE trial or the start of a new treatment cycle in the OLE trial and more than 21 days since the last dose of IMP.
- Pregnant and lactating women and those intending to become pregnant during the trial.
- Patients with clinical evidence of other significant serious disease or patients who underwent a recent or have a planned major surgery, or patients who (intend to) use prohibited medications (see protocol) and therapies during the trial, or any other reason which could confound the results of the trial or put the patient at undue risk.
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): NCT04280718
Responsible Party: | argenx |
ClinicalTrials.gov Identifier: | NCT04280718 |
Other Study ID Numbers: |
ARGX-113-1902 2019-003107-35 ( EudraCT Number ) |
First Posted: | February 21, 2020 Key Record Dates |
Last Update Posted: | August 4, 2023 |
Last Verified: | August 2023 |
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 |
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Chronic Disease Disease Attributes Pathologic Processes |