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Filing 8k materialCTGOV9/19/2026, 11:27:51 AM
Trial registeredCTGOV9/19/2026, 12:20:24 PM
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Trial registeredCTGOV9/19/2026, 4:35:00 PM
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Trial registeredCTGOV9/19/2026, 4:35:25 PM
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Trial registeredCTGOV9/19/2026, 4:35:26 PM
Trial registeredCTGOV9/19/2026, 4:35:27 PM
Trial registeredCTGOV9/22/2026, 5:05:31 AM
Trial site count changeCTGOV9/22/2026, 5:05:31 AM
Trial site count changeCTGOV9/23/2026, 5:06:01 AM
Trial site count changeCTGOV9/23/2026, 5:06:07 AM
Trial site count changeCTGOV9/23/2026, 5:06:08 AM
Trial completion date change| completion_date | 2029-05-12 | → | 2030-07-30 |
| primary_completion_date | 2029-01-20 | → | 2030-07 |
CTGOV9/23/2026, 5:06:08 AM
Trial status change| overall_status | Recruiting | → | Not yet recruiting |
CTGOV9/23/2026, 5:06:09 AM
Trial site count changeCTGOV9/23/2026, 5:07:01 AM
Trial site count changeCTGOV9/24/2026, 5:05:46 AM
Trial site count changeCTGOV9/24/2026, 5:05:47 AM
Trial site count changeCTGOV9/24/2026, 5:05:49 AM
Trial site count changeCTGOV9/24/2026, 5:06:40 AM
Trial site count changeCTGOV9/24/2026, 5:06:45 AM
Trial site count changeCTGOV9/26/2026, 5:08:06 AM
Trial site count changeCTGOV9/26/2026, 5:08:07 AM
Trial completion date change| completion_date | 2026-07-31 | → | 2030-05 |
CTGOV9/26/2026, 5:08:08 AM
Trial endpoint change| secondary_outcomes | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
CTGOV9/26/2026, 5:08:08 AM
Trial eligibility change| eligibility_criteria | Inclusion Criteria:
* At least 18 years old
* Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
* GBS-related weakness beginning within 7 days before the first study treatment
* GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
* Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
* Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Exclusion Criteria:
* History of a previous GBS episode or diagnosis of an atypical GBS variant
* Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
* Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
* IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
* Recent treatment with IVIg or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies | → | Inclusion Criteria:
* Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
* GBS-related weakness beginning within 7 days before the first study treatment
* GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
* Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
* Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Exclusion Criteria:
* History of a previous GBS episode or diagnosis of an atypical GBS variant
* Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
* Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
* IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
* Recent treatment with IVIg or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies |
EDGAR9/29/2026, 5:30:00 AM
Filing 8k materialMARKET10/8/2026, 5:30:00 AM
Unusual volumeEDGAR10/8/2026, 5:30:00 AM
Filing 8k materialMARKET10/8/2026, 5:30:00 AM
Unusual moveCTGOV10/9/2026, 5:07:07 AM
Trial site count changeCTGOV10/15/2026, 5:06:28 AM
Trial status change| overall_status | Recruiting | → | Completed |
CTGOV10/15/2026, 5:06:28 AM
Trial enrollment change| enrollment_type | ESTIMATED | → | ACTUAL |
CTGOV10/15/2026, 5:06:28 AM
Trial completion date change| completion_date | 2026-09-18 | → | 2026-09-23 |
| primary_completion_date | 2026-09-18 | → | 2026-09-23 |
CTGOV10/17/2026, 5:06:18 AM
Trial site count changeCTGOV10/17/2026, 5:06:18 AM
Trial site count changeCTGOV10/17/2026, 5:06:19 AM
Trial site count changeCTGOV10/17/2026, 5:06:20 AM
Trial site count changeCTGOV10/17/2026, 5:06:55 AM
Trial site count changeCTGOV10/17/2026, 5:06:58 AM
Trial site count changeCTGOV10/17/2026, 5:07:06 AM
Trial site count changeCTGOV10/17/2026, 5:07:30 AM
Trial status change| overall_status | Recruiting | → | Active, not recruiting |
CTGOV10/17/2026, 5:07:30 AM
Trial enrollment change| enrollment_type | ESTIMATED | → | ACTUAL |
| enrollment_count | 81 | → | 87 |
CTGOV10/17/2026, 5:07:30 AM
Trial completion date change| completion_date | 2027-09 | → | 2027-10 |
| primary_completion_date | 2027-02 | → | 2027-03 |
CTGOV10/17/2026, 5:07:35 AM
Trial site count changeEDGAR10/19/2026, 5:30:00 AM
Filing 8k materialCTGOV10/20/2026, 5:05:04 AM
Trial completion date change| completion_date | 2026-10-01 | → | 2027-10 |
| primary_completion_date | 2026-10-01 | → | 2027-10 |
CTGOV10/20/2026, 5:05:04 AM
Trial endpoint change| primary_outcomes | [object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object] |
| secondary_outcomes | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
CTGOV10/20/2026, 5:05:04 AM
Trial eligibility change| eligibility_criteria | Inclusion Criteria:
1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period.
Note: If a participant has had an SAE during the ARGX-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. The decision of enrolling the participant will be evaluated case by case.
3a. Agree to use contraceptives consistent with local regulations and the following:
• Female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving IMP.
In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP), the following criteria apply:
4\. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
5\. Participant has completed a 52-week treatment period.
Exclusion criteria:
1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
2. Use of any other investigational drug or participation in any other investigational trial
3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC | → | Inclusion Criteria:
* Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
* Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period.
* Agree to use contraceptives consistent with local regulations.
* In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period, the participant has completed a 52-week treatment period.
Exclusion criteria:
* Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines).
* Use of any other investigational drug or participation in any other investigational trial.
* Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients.
* Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC. |
EDGAR10/22/2026, 5:30:00 AM
Filing 8k materialCTGOV10/28/2026, 5:06:13 AM
Trial status change| overall_status | Not yet recruiting | → | Recruiting |
CTGOV10/28/2026, 5:06:13 AM
Trial site count changeCTGOV10/29/2026, 5:05:15 AM
Trial eligibility change| eligibility_criteria | Inclusion Criteria:
* Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
* GBS-related weakness beginning within 7 days before the first study treatment
* GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
* Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
* Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Exclusion Criteria:
* History of a previous GBS episode or diagnosis of an atypical GBS variant
* Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
* Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
* IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
* Recent treatment with IVIg or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies | → | Inclusion Criteria:
* Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria
* GBS-related weakness beginning within 7 days before the first study treatment
* GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline
* Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms
* Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown.
Exclusion Criteria:
* History of a previous GBS episode or diagnosis of an atypical GBS variant
* Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency
* Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk
* IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe
* Recent treatment with IVIg except for a single IVIg dose administered during screening and within 24 hours before the first investigational medicinal product (IMP) dose for the current GBS episode or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies |
CTGOV10/29/2026, 5:05:15 AM
Trial completion date change| completion_date | 2027-07 | → | 2028-06 |
| primary_completion_date | 2026-12 | → | 2027-06 |
CTGOV10/30/2026, 5:05:36 AM
Trial status change| overall_status | Recruiting | → | Active, not recruiting |
CTGOV10/30/2026, 5:05:36 AM
Trial enrollment change| enrollment_type | ESTIMATED | → | ACTUAL |
| enrollment_count | 12 | → | 15 |
CTGOV10/31/2026, 5:05:19 AM
Trial site count changeCTGOV10/31/2026, 5:05:35 AM
Trial completion date change| completion_date | 2026-05-15 | → | 2027-05-15 |