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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05681481
Registration number
NCT05681481
Ethics application status
Date submitted
8/12/2022
Date registered
12/01/2023
Date last updated
15/08/2024
Titles & IDs
Public title
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
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Scientific title
An Open-label Extension Study of ARGX-113-2009 to Evaluate the Long Term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
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Secondary ID [1]
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0
ARGX-113-2010
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Universal Trial Number (UTN)
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Trial acronym
BALLAD+
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bullous Pemphigoid
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0
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Condition category
Condition code
Skin
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0
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0
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Dermatological conditions
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Inflammatory and Immune System
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0
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - efgartigimod PH20 SC
Treatment: Drugs - Prednisone
Experimental: efgartigimod PH20 SC - participants receiving efgartigimod PH20 SC on top of Prednisone
Treatment: Other: efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Treatment: Drugs: Prednisone
Oral Prednisone
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events
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Assessment method [1]
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Incidence of treatment-emergent adverse events
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Timepoint [1]
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Up to 56 weeks
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Primary outcome [2]
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Severity of treatment-emergent adverse events
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Assessment method [2]
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Severity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) definitions (current version): Grade 1 (mild) to Grade 5 (death related to adverse event)
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Timepoint [2]
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Up to 56 weeks
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Primary outcome [3]
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Incidence of serious adverse events
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Assessment method [3]
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Incidence of serious adverse events
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Timepoint [3]
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0
Up to 56 weeks
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Primary outcome [4]
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Severity of serious adverse events
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Assessment method [4]
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0
Severity of serious adverse events
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Timepoint [4]
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0
Up to 56 weeks
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Primary outcome [5]
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Incidence of adverse events of special interest
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Assessment method [5]
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Incidence of adverse events of special interest
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Timepoint [5]
0
0
Up to 56 weeks
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Primary outcome [6]
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Severity of adverse events of special interest
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Assessment method [6]
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0
Severity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events ( CTCAE) definitions (current version): Grade 1 (mild) to Grade 5 (death related to adverse event)
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Timepoint [6]
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0
Up to 56 weeks
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Primary outcome [7]
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Rate of treatment discontinuation because of safety concerns
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Assessment method [7]
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Rate of treatment discontinuation because of safety concerns
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Timepoint [7]
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Up to 56 weeks
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Secondary outcome [1]
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Proportion of participants achieving complete remission while off oral corticosteroids for = 8 weeks
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Assessment method [1]
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Proportion of participants achieving complete remission while off oral corticosteroids for = 8 weeks
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Timepoint [1]
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Up to 56 weeks
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Secondary outcome [2]
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Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for = 8 weeks
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Assessment method [2]
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Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for = 8 weeks
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Timepoint [2]
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Up to 56 weeks
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Secondary outcome [3]
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Proportion of participants achieving complete remission while on minimal oral corticosteroids therapy for = 8 weeks
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Assessment method [3]
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Minimal oral corticosteroid therapy is defined as =0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid)
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Timepoint [3]
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0
Up to 56 weeks
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Secondary outcome [4]
0
0
Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for = 8 weeks
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Assessment method [4]
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Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for = 8 weeks
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Timepoint [4]
0
0
Up to 56 weeks
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Secondary outcome [5]
0
0
Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for = 8 weeks
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Assessment method [5]
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Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for = 8 weeks
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Timepoint [5]
0
0
Up to 56 weeks
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Secondary outcome [6]
0
0
Duration of sustained remission
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Assessment method [6]
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Duration of sustained remission
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Timepoint [6]
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0
Up to 56 weeks
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Secondary outcome [7]
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Proportion of participants who relapse
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Assessment method [7]
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Proportion of participants who relapse
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Timepoint [7]
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Up to 56 weeks
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Secondary outcome [8]
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Time to relapse
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Assessment method [8]
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Time to relapse
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Timepoint [8]
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Up to 56 weeks
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Secondary outcome [9]
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Incidence of relapse
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Assessment method [9]
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Incidence of relapse
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Timepoint [9]
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Up to 56 weeks
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Secondary outcome [10]
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Severity of relapse
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Assessment method [10]
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Severity of relapse will be assessed based on the Bullous Pemphigoid Disease Area Index (BPDAI)
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Timepoint [10]
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Up to 56 weeks
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Secondary outcome [11]
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Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
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Assessment method [11]
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Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
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Timepoint [11]
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For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [12]
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Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
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Assessment method [12]
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Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
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Timepoint [12]
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For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
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Secondary outcome [13]
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Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
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Assessment method [13]
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Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
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Timepoint [13]
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For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [14]
0
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Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
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Assessment method [14]
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Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
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Timepoint [14]
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For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
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Secondary outcome [15]
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Itch Numerical Rating Scale (NRS) over time
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Assessment method [15]
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Itch Numerical Rating Scale (NRS) over time
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Timepoint [15]
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For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [16]
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Itch Numerical Rating Scale (NRS) over time
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Assessment method [16]
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Itch Numerical Rating Scale (NRS) over time
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Timepoint [16]
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0
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks until efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
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Secondary outcome [17]
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0
Rate of treatment failure
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Assessment method [17]
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0
Rate of treatment failure
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Timepoint [17]
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0
Up to 56 weeks
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Secondary outcome [18]
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0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
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Assessment method [18]
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0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
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Timepoint [18]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
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Secondary outcome [19]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
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Assessment method [19]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
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Timepoint [19]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
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Secondary outcome [20]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
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Assessment method [20]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
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Timepoint [20]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
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Secondary outcome [21]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
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Assessment method [21]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
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Timepoint [21]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
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Secondary outcome [22]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
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Assessment method [22]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
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Timepoint [22]
0
0
For participants not requiring treatment with efgartigimod at rollover: at weeks 0, 24 and 48.
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Secondary outcome [23]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
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Assessment method [23]
0
0
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
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Timepoint [23]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: weeks 0, 8, every 16 weeks until and after efgartigimod treatment stop and at week 48.
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Secondary outcome [24]
0
0
EQ-5D-5L scores over time
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Assessment method [24]
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EQ-5D-5L scores over time
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Timepoint [24]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
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Secondary outcome [25]
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0
EQ-5D-5L scores over time
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Assessment method [25]
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0
EQ-5D-5L scores over time
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Timepoint [25]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
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Secondary outcome [26]
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Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
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Assessment method [26]
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Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
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Timepoint [26]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
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Secondary outcome [27]
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0
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
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Assessment method [27]
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0
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
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Timepoint [27]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
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Secondary outcome [28]
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0
Dermatology Life Quality Index (DLQI) scores over time
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Assessment method [28]
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0
Dermatology Life Quality Index (DLQI) scores over time
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Timepoint [28]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48.
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Secondary outcome [29]
0
0
Dermatology Life Quality Index (DLQI) scores over time
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Assessment method [29]
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0
Dermatology Life Quality Index (DLQI) scores over time
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Timepoint [29]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 8, every 16 weeks until and after efgartigimod PH20 SC treatment stop and at week 48.
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Secondary outcome [30]
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Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
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Assessment method [30]
0
0
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
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Timepoint [30]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [31]
0
0
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
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Assessment method [31]
0
0
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
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Timepoint [31]
0
0
For participants continuing/starting efgartigimod PH20 SC treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 4 weeks to efgartigimod stop, every 8 weeks after efgartigimod stop and at weeks 48, 52 and 56.
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Secondary outcome [32]
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0
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Assessment method [32]
0
0
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Timepoint [32]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [33]
0
0
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Assessment method [33]
0
0
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Timepoint [33]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.
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Secondary outcome [34]
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0
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Assessment method [34]
0
0
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Timepoint [34]
0
0
For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56.
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Secondary outcome [35]
0
0
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Assessment method [35]
0
0
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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Timepoint [35]
0
0
For participants continuing/starting efgartigimod treatment at rollover or relapse: at weeks 0, 2, 4 and 8 and then every 8 weeks until and after efgartigimod PH20 SC stop and at weeks 48, 52 and 56.
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Eligibility
Key inclusion criteria
* Has completed the week 36 visit of ARGX-113-2009
* Is capable of providing signed informed consent and complying with protocol requirements
* Agrees to use contraceptive measures consistent with local regulations and the following: Women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug and must use one of the contraception methods described in the protocol from signing the ICF until the last dose of the study drug
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Clinically significant disease, recent major surgery (within 3 months of baseline), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion would confound the results of the study or put the participant at undue risk
* Known hypersensitivity to the study drug or 1 of its excipients
* Permanently discontinued IMP in ARGX-113-2009 due to an adverse event (AE) considered related to the study drug and for whom the benefit/risk balance is not considered positive
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/03/2026
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
0
0
Premier Specialists - Kogarah
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Recruitment postcode(s) [1]
0
0
2217 - Kogarah
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Michigan
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Missouri
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Ohio
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Country [7]
0
0
Bulgaria
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State/province [7]
0
0
Sofia
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Country [8]
0
0
China
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State/province [8]
0
0
Chengdu
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Country [9]
0
0
Croatia
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State/province [9]
0
0
Zagreb
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Country [10]
0
0
Czechia
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State/province [10]
0
0
Praha
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Country [11]
0
0
Germany
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State/province [11]
0
0
Berlin
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Country [12]
0
0
Germany
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State/province [12]
0
0
Dresden
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Country [13]
0
0
Germany
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State/province [13]
0
0
Düsseldorf
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Country [14]
0
0
Germany
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State/province [14]
0
0
Kiel
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Country [15]
0
0
Germany
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State/province [15]
0
0
München
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Country [16]
0
0
Germany
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State/province [16]
0
0
Würzburg
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Country [17]
0
0
Greece
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State/province [17]
0
0
Athens
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Country [18]
0
0
Greece
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State/province [18]
0
0
Thessaloníki
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Country [19]
0
0
Hungary
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State/province [19]
0
0
Budapest
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Country [20]
0
0
Israel
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State/province [20]
0
0
Ramat Gan
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Country [21]
0
0
Italy
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State/province [21]
0
0
Catania
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Country [22]
0
0
Italy
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State/province [22]
0
0
Firenze
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Country [23]
0
0
Italy
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State/province [23]
0
0
Genova
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Country [24]
0
0
Italy
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State/province [24]
0
0
Milano
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Country [25]
0
0
Italy
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State/province [25]
0
0
Pavia
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Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Roma
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Country [27]
0
0
Italy
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State/province [27]
0
0
Rome
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Country [28]
0
0
Japan
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State/province [28]
0
0
Sapporo
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Country [29]
0
0
Netherlands
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State/province [29]
0
0
Groningen
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Country [30]
0
0
Serbia
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State/province [30]
0
0
Belgrade
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Country [31]
0
0
Slovakia
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State/province [31]
0
0
Bratislava
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Country [32]
0
0
Slovakia
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State/province [32]
0
0
Trnava
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Country [33]
0
0
Spain
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State/province [33]
0
0
Granada
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Country [34]
0
0
Spain
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State/province [34]
0
0
Madrid
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Country [35]
0
0
Spain
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State/province [35]
0
0
Valencia
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Country [36]
0
0
United Kingdom
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State/province [36]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
argenx
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Summary
Brief summary
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 receive efgartigimod PH20 SC. After the first 5 visits, the participants will visit the study centers 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 corticosterioids can be administered at the investigator's indiscretion
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Trial website
https://clinicaltrials.gov/study/NCT05681481
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Trial related presentations / publications
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Public notes
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Contacts
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Sabine Coppieters, MD
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857-350-4834
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results not provided in
https://clinicaltrials.gov/study/NCT05681481
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