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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515832-59-00 | EU Trial (CTIS) Number |
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Sponsor decision
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The purpose of this study is to evaluate the safety of efgartigimod PH20 SC over a longer period of time in adult participants with moderate-to-severe bullous pemphigoid (BP) who have completed ARGX-113-2009 study. The study will also evaluate the efficacy of efgartigimod PH20 SC.
Eligible participants can roll over from the main study (ARGX-113-2009) to this open-label extension study (ARGX-113-2010). The study consists of a treatment period of up to 48 weeks in which participants could receive efgartigimod PH20 SC according to their clinical status. After the first 5 visits, the participants will visit the study centres at least once every 4 weeks. The participants who are not receiving efgartigimod PH20 SC (after the main study or currently on the study), will enter an observation period with study visits at least once every 8 weeks. If the participant relapses, they can re-enter the treatment period where they will receive efgartigimod PH20 SC. The treatment and observation period is followed by a follow-up period of 8 weeks. Oral or topical corticosteroids can be administered at the investigator's discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efgartigimod PH20 SC | Experimental | participants receiving efgartigimod PH20 SC on top of Prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| efgartigimod PH20 SC | Biological | Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. | Up to 56 weeks |
| Number of Participants Who Discontinued Treatment Because of Safety Concerns | Up to 56 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving CRoff for ≥ 8 Weeks | CRoff = complete remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. | Up to 56 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | United States | ||
| First OC Dermatology |
The study enrolled participants with bullous pemphigoid (BP) who completed the week-36/end-of-treatment period (EoTP) visit in ARGX-113-2009. A total of 64 participants (of 98 eligible participants) rolled over from ARGX-113-2009.
This study was conducted at 38 sites that enrolled participants in 17 countries. On 13 Jan 2025 the sponsor terminated the study early due to a lack of efficacy of efgartigimod when administered with concomitant OCS in the antecedent study (ARGX-113-2009).
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| ID | Title | Description |
|---|---|---|
| FG000 | Efgartigimod PH20 SC | Participants rolling over from ARGX-113-2009 study, eligible to receive efgartigimod PH20 SC in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2024 | Dec 12, 2025 |
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| Prednisone | Drug | Oral Prednisone |
|
| Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks |
CRoff / PRoff = complete or partial remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. |
| Up to 56 weeks |
| Number of Participants Achieving CRmin for ≥ 8 Weeks | Minimal oCRmin = complete remission while being on minimal dose of OCS for ≥ 8 weeks. OCS = oral corticosteroid. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid) | Up to 56 weeks |
| Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks | CR = complete remission; OCS = oral corticosteroids; Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus | Up to 56 weeks |
| Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks | CR = complete remission; PR = partial remission; OCS = oral corticosteroids Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. | Up to 56 weeks |
| Duration of Sustained Remission | Sustained remission is defined as healing of lesions with no nontransient lesions (ie, BPDAI activity score of 0) and absence of pruritus while the participant was off concurrent BP therapy (and, for participants enrolled prior to protocol amendment 2, efgartigimod PH20 SC) for ≥8 weeks. New lesions that heal within 1 week or pruritus lasting <1 week and clearing without treatment were not considered to change the condition of sustained remission. | Up to 56 weeks |
| Number of Participants Who Relapsed | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate | Up to 56 weeks |
| Time to Relapse | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate | Up to 56 weeks |
| BPDAI Activity Score, Percent Change From Baseline to Last Assessment | The Bullous Pemphigoid Disease Area Index (BPDAI) is an internationally validated tool to objectively measure disease activity. The BPDAI differentiates scores for skin (erosions/blisters and urticaria/erythema) and mucous membrane activity in several anatomical locations. BPDAI activity scores range from 0 to 360, with a higher score representing more severe disease. | Up to 56 weeks |
| IGA-BP Score at Last Assessment | The Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) is a tool used to asses BP disease activity and severity. The IGA-BP categorizes the severity of BP on a numerical scale of 0 (clear) to 4 (severe). | Up to 56 weeks |
| Itch NRS 24-hour Average Score, Change From Baseline to Last Assessment | The Itch Numerical Rating Scale (NRS) is used to indicate pruritic symptoms of BP. The score varies between 0 (best outcome) to 10 (worst outcome) | Up to 56 weeks |
| Number of Participants Who Failed Treatment | Treatment failure is defined as the absence of CDA despite receiving efgartigimod PH20 SC with escalated dosages of prednisone (or equivalent OCS) | Up to 56 weeks |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Miami Dermatology and Laser Institute | Miami | Florida | 33173 | United States |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
| Premier Specialists | Kogarah | 2217 | Australia |
| Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia | 1431 | Bulgaria |
| West China Hospital of Sichuan University | Chengdu | 610041 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | 200025 | China |
| Poliklinika Solmed | Zagreb | 10000 | Croatia |
| Fakultni nemocnice Bulovka | Prague | 180 00 | Czechia |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Carl Gustav Carus an der TU Dresden | Dresden | 01307 | Germany |
| Universitatsklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| LMU Klinikum der Universität | München | 80337 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Hospital of Venereal and Skin Diseases A.Syggros | Athens | 16121 | Greece |
| Hospital Of Skin And Venereal Diseases of Thessaloniki | Thessaloniki | 54643 | Greece |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Sheba Medical Center - PPDS | Ramat Gan | 5262100 | Israel |
| Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele | Catania | 95123 | Italy |
| Azienda USL Toscana Centro - Ospidale Piero Palagi | Florence | 50122 | Italy |
| Azienda Sanitaria Di Firenze | Florence | 50125 | Italy |
| Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | 27100 | Italy |
| IDI IRCCS - Istituto Dermopatico dell'Immacolata | Roma | 00167 | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Rome | 00168 | Italy |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| Universitair Medisch Centrum Groningen | Groningen | 9713 GZ | Netherlands |
| University Clinical Center of Serbia - PPDS | Belgrade | 11000 | Serbia |
| Univerzitna nemocnica Bratislava | Bratislava | 821 06 | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 91702 | Slovakia |
| Hospital Universitario Clínico San Cecilio | Granada | 18016 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efgartigimod PH20 SC | Participants rolling over from ARGX-113-2009 study, eligible to receive efgartigimod PH20 SC in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. | Safety analysis set: all participants who rolled over from ARGX-113-2009, provided informed consent for ARGX-113-2010, and received at least 1 dose of efgartigimod PH20 SC in ARGX-113-2010. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Discontinued Treatment Because of Safety Concerns | Safety analysis set: all participants who rolled over from ARGX-113-2009, provided informed consent for ARGX-113-2010, and received at least 1 dose of efgartigimod PH20 SC in ARGX-113-2010. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving CRoff for ≥ 8 Weeks | CRoff = complete remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. | Only participants evaluable for CRoff for >=8 weeks are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks | CRoff / PRoff = complete or partial remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. | Only participants evaluable for CRoff or PRoff for >=8 weeks are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving CRmin for ≥ 8 Weeks | Minimal oCRmin = complete remission while being on minimal dose of OCS for ≥ 8 weeks. OCS = oral corticosteroid. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid) | Only participants evaluable for CRmin for >=8 weeks are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks | CR = complete remission; OCS = oral corticosteroids; Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus | Only participants evaluable for CR while off both OCS therapy and Efgartigimod PH20 SC for >=8 weeks are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks | CR = complete remission; PR = partial remission; OCS = oral corticosteroids Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. | Only participants evaluable for CR or PR while off both OCS therapy and Efgartigimod PH20 SC for >=8 weeks are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Sustained Remission | Sustained remission is defined as healing of lesions with no nontransient lesions (ie, BPDAI activity score of 0) and absence of pruritus while the participant was off concurrent BP therapy (and, for participants enrolled prior to protocol amendment 2, efgartigimod PH20 SC) for ≥8 weeks. New lesions that heal within 1 week or pruritus lasting <1 week and clearing without treatment were not considered to change the condition of sustained remission. | Only participants evaluable for duration of sustained remission are reported here. | Posted | Median | 95% Confidence Interval | days | Up to 56 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Relapsed | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate | Rollover set: all participants who rolled over from ARGX-113-2009 and provided informed consent for ARGX-113-2010. Only participants evaluable for relapse from CDA, CR or PR onset are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to Relapse | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate | Only participants evaluable for time to relapse from CDA, CR or PR onset are reported here. | Posted | Median | 95% Confidence Interval | days | Up to 56 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | BPDAI Activity Score, Percent Change From Baseline to Last Assessment | The Bullous Pemphigoid Disease Area Index (BPDAI) is an internationally validated tool to objectively measure disease activity. The BPDAI differentiates scores for skin (erosions/blisters and urticaria/erythema) and mucous membrane activity in several anatomical locations. BPDAI activity scores range from 0 to 360, with a higher score representing more severe disease. | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | Posted | Mean | Standard Deviation | Percent change | Up to 56 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | IGA-BP Score at Last Assessment | The Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) is a tool used to asses BP disease activity and severity. The IGA-BP categorizes the severity of BP on a numerical scale of 0 (clear) to 4 (severe). | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | Posted | Number | Participants | Up to 56 weeks |
|
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| Secondary | Itch NRS 24-hour Average Score, Change From Baseline to Last Assessment | The Itch Numerical Rating Scale (NRS) is used to indicate pruritic symptoms of BP. The score varies between 0 (best outcome) to 10 (worst outcome) | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | Posted | Mean | Standard Deviation | score on a scale | Up to 56 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Failed Treatment | Treatment failure is defined as the absence of CDA despite receiving efgartigimod PH20 SC with escalated dosages of prednisone (or equivalent OCS) | Only participants evaluable for treatment failure are reported here. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
|
Up to 56 weeks
Adverse events are reported for the safety analysis set which includes the 50 participants who received at least 1 dose of efgartigimod PH20 SC in ARGX-113-2010. Any clinically significant changes occurring during the study were reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efgartigimod PH20 SC | Participants rolling over from ARGX-113-2009 study, eligible to receive efgartigimod PH20 SC in this study. | 1 | 50 | 13 | 50 | 38 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Streptococcal sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Manager | argenx BV | +32 93103400 | regulatory@argenx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2025 | Dec 12, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010391 | Pemphigoid, Bullous |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Other |
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