- Proportion of participants achieving complete remission while off oral corticosteroids for ≥ 8 weeks [ Time Frame: Up to 56 weeks ]
Proportion of participants achieving complete remission while off oral corticosteroids for ≥ 8 weeks
- Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for ≥ 8 weeks [ Time Frame: Up to 56 weeks ]
Proportion of participants achieving complete remission or partial remission while off oral corticosteroids for ≥ 8 weeks
- Proportion of participants achieving complete remission while on minimal oral corticosteroids therapy for ≥ 8 weeks [ Time Frame: Up to 56 weeks ]
Minimal oral corticosteroid therapy is defined as ≤0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid)
- Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks [ Time Frame: Up to 56 weeks ]
Proportion of participants achieving complete remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
- Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks [ Time Frame: Up to 56 weeks ]
Proportion of participants achieving complete remission or partial remission while off both oral corticosteroids and efgartigimod PH20 SC for ≥ 8 weeks
- Duration of sustained remission [ Time Frame: Up to 56 weeks ]
Duration of sustained remission
- Proportion of participants who relapse [ Time Frame: Up to 56 weeks ]
Proportion of participants who relapse
- Time to relapse [ Time Frame: Up to 56 weeks ]
Time to relapse
- Incidence of relapse [ Time Frame: Up to 56 weeks ]
Incidence of relapse
- Severity of relapse [ Time Frame: Up to 56 weeks ]
Severity of relapse will be assessed based on the Bullous Pemphigoid Disease Area Index (BPDAI)
- Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
- Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time [ Time Frame: 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. ]
Bullous Pemphigoid Disease Area Index (BPDAI) activity scores over time
- Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
- Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time [ Time Frame: 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. ]
Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) scores over time
- Itch Numerical Rating Scale (NRS) over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Itch Numerical Rating Scale (NRS) over time
- Itch Numerical Rating Scale (NRS) over time [ Time Frame: 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. ]
Itch Numerical Rating Scale (NRS) over time
- Rate of treatment failure [ Time Frame: Up to 56 weeks ]
Rate of treatment failure
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time [ Time Frame: 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. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index - Aggregate Improvement Score (GTI-AIS) over time
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time [ Time Frame: 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. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Cumulative Worsening Score (GTI-CWS) over time
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time [ Time Frame: For participants not requiring treatment with efgartigimod at rollover: at weeks 0, 24 and 48. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
- Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time [ Time Frame: 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. ]
Glucocorticoid Toxicity Index (GTI)-related scores, including the Glucocorticoid Toxicity Index Specific List (GTI-SL) over time
- EQ-5D-5L scores over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48. ]
EQ-5D-5L scores over time
- EQ-5D-5L scores over time [ Time Frame: 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. ]
EQ-5D-5L scores over time
- Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48. ]
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
- Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time [ Time Frame: 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. ]
Autoimmune Bullous Disease Quality of Life (ABQoL) scores over time
- Dermatology Life Quality Index (DLQI) scores over time [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 24 and 48. ]
Dermatology Life Quality Index (DLQI) scores over time
- Dermatology Life Quality Index (DLQI) scores over time [ Time Frame: 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. ]
Dermatology Life Quality Index (DLQI) scores over time
- Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 2, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
- Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels [ Time Frame: 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. ]
Percent changes from baseline over time for anti-BP180 and anti-BP-230 antibody levels
- Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels) [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
- Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels) [ Time Frame: 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. ]
Incidence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
- Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels) [ Time Frame: For participants not requiring treatment with efgartigimod PH20 SC at rollover: at weeks 0, 4, 8, 16, 24, 32, 40, 48 and 56. ]
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
- Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels) [ Time Frame: 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. ]
Prevalence of antidrug antibody(ies) (ADA) against efgartigimod (serum levels)
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ARGX-113-2010 is an open-label extension study with the aim to provide supporting evidence that efgartigimod PH20 SC is a safe and effective long-term treatment for bullous pemphigoid (BP), providing symptom control and eventually remission, while also reducing the cumulative exposure to oral corticosteroids (OCS).
All participants who complete the end-of-treatment period (EoTP) visit at week 36 in ARGX-113-2009 will be invited to enroll.
In ARGX-113-2009, participants received efgartigimod PH20 SC or placebo with concurrent OCS, or rescue therapy (without efgartigimod PH20 SC or placebo). Depending on their clinical status at the time of rollover into ARGX-113-2010, participants may stop, continue or initiate efgartigimod PH20 SC treatment. In ARGX-113-2010, participants will stop efgartigimod PH20 SC treatment when they achieve complete remission (CR) or partial remission (PR) while being off other concurrent BP therapy for at least 8 weeks. Participants not in CR or PR while off OCS for ≥8 weeks and not on rescue therapy will either start or continue efgartigimod PH20 SC treatment, while maintaining the treatment allocation of ARGX-113-2009 blinded. Participants may also be retreated with efgartigimod PH20 SC after a relapse. In this study, loading doses of 2000 mg (on day 1 and day 8 of a treatment course) and weekly maintenance doses of 1000 mg will be used.
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