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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05267600
Other study ID # ARGX-113-2009
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 9, 2022
Est. completion date March 28, 2025

Study information

Verified date January 2024
Source argenx
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: - Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. - Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis). Other than differences in main goals, endpoints, and statistical analyses, parts A and B are identical in schedule, structure, assessments, and conduct.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20, a permeation enhancer
Other:
placebo
Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer
Drug:
Prednisone
Oral Prednisone

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Sponsors (1)

Lead Sponsor Collaborator
argenx

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  China,  Croatia,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Latvia,  Netherlands,  Poland,  Romania,  Serbia,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for =8 weeks at week 36 at week 36
Secondary Cumulative dose of oral corticosteroid (OCS) from baseline to week 36 up to week 36
Secondary Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for =8 weeks at week 36 at week 36
Secondary Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo and have been off oral corticosteroid (OCS) therapy for =8 weeks at week 36 at week 36
Secondary Proportion of participants who achieve an Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) score of 0 or 1 while receiving efgartigimod PH20 SC or placebo at any time through week 36 up to week 36
Secondary Changes from baseline in the Bullous Pemphigoid Disease Area Index (BPDAI) activity score up to week 36
Secondary Proportion of participants who are in complete remission (CR) while receiving efgartigimod PH20 SC or placebo and have been receiving minimal oral corticosteroid (OCS) therapy for =8 weeks at week 36 Minimal oral corticosteroid (OCS) therapy is defined as =0.1 mg/kg/day of prednisone (or an equivalent dose of another OCS). at week 36
Secondary Time to achieve control of disease activity (CDA) up to week 36
Secondary Time to achieve complete remission (CR) up to week 36
Secondary Time to achieve complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Time to achieve complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Time to achieve complete remission (CR) while off oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Time to achieve relapse up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit control of disease activity (CDA) up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while on minimal oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR)/partial remission (PR) while off oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit complete remission (CR) while off oral corticosteroid (OCS) therapy for =8 weeks up to week 36
Secondary Cumulative oral corticosteroid (OCS) dose for the participant at the time points when they exhibit relapse up to week 36
Secondary Proportion of participants who receive rescue therapy before week 36 at week 36
Secondary Proportion of participants who achieve control of disease activity (CDA) while receiving efgartigimod PH20 SC or placebo and remain free of relapse through week 36 up to week 36
Secondary Changes from baseline in the 24-hour average itch score from the Itch Numerical Rating Scale (Itch NRS) up to week 36
Secondary Changes from baseline in the 24-hour worst itch score from the Itch Numerical Rating Scale (Itch NRS) up to week 36
Secondary Incidence of treatment emergent adverse events (TEAEs) up to 46 weeks
Secondary Severity of treatment emergent adverse events (TEAEs) up to 46 weeks
Secondary Incidence of adverse events of special interest (AESIs) up to 46 weeks
Secondary Severity of adverse events of special interest (AESIs) up to 46 weeks
Secondary Incidence of serious adverse events (SAEs) up to 46 weeks
Secondary Severity of serious adverse events (SAEs) up to 46 weeks
Secondary The Aggregate Improvement Score (AIS) from the Glucocorticoid Toxicity Index (GTI) up to week 36
Secondary The Cumulative Worsening Score (CWS) from the Glucocorticoid Toxicity Index (GTI) up to week 36
Secondary The Glucocorticoid Toxicity Index Specific List (GTI-SL) up to week 36
Secondary EuroQol 5-Dimension 5-Level (EQ-5D-5L) scores over time up to week 36
Secondary Dermatology Life Quality Index (DLQI) scores over time up to week 36
Secondary Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time up to week 36
Secondary Efgartigimod serum concentrations up to week 43
Secondary Percent change of total IgG serum levels from baseline over time up to 46 weeks
Secondary Percent change of Anti-BP180 and anti-BP230 antibodies from baseline over time up to 46 weeks
Secondary Incidence of Antidrug antibodies (ADA) against efgartigimod (in serum) and antibodies produced against rHuPH20 (in plasma) up to 46 weeks
Secondary Number of participants (or their caregivers) who complete the (self-)administration training at study sites up to week 32
Secondary Percentage of participants (or their caregivers) who complete the (self-)administration training at study sites up to week 32
Secondary Number of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC up to week 32
Secondary Percentage of participants (or their caregivers) who are determined by site staff to be sufficiently competent in (self-)administering efgartigimod PH20 SC up to week 32
Secondary Number of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision up to week 35
Secondary Percentage of participants (or their caregivers) who successfully (self-)administer efgartigimod PH20 SC under site staff supervision up to week 35
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