Bullous Pemphigoid Clinical Trial
Official 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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03286582 -
A Proof-of-Concept Study of Topical AC-203 in Patients With Bullous Pemphigoid
|
Phase 2 | |
| Completed |
NCT02837965 -
Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid
|
||
| Recruiting |
NCT03636763 -
Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?
|
||
| Recruiting |
NCT00802243 -
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
|
Phase 2 | |
| Completed |
NCT05649579 -
Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
|
||
| Active, not recruiting |
NCT04206553 -
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid
|
Phase 2/Phase 3 | |
| Completed |
NCT00431119 -
Azathioprine or Mycophenolate Mofetil for Bullous Pemphigoid
|
Phase 2 | |
| Completed |
NCT04563923 -
Treatment of Bullous Pemphigoid With Avdoralimab (IPH5401), an Anti-C5aR1 Monoclonal Antibody
|
Phase 2 | |
| Completed |
NCT03320798 -
Impact of Neurological Diseases on the Prognosis of Bullous Pemphigoid: A Retrospective Study of 178 Patients
|
N/A | |
| Completed |
NCT03272958 -
Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid
|
||
| Completed |
NCT02883894 -
Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid
|
N/A | |
| Completed |
NCT00809822 -
Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.
|
Phase 2 | |
| Recruiting |
NCT05594472 -
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid
|
Phase 3 | |
| Withdrawn |
NCT05061771 -
Nomacopan Therapy in Adult Patients With Bullous Pemphigoid Receiving Adjunct Oral Corticosteroid Therapy (ARREST-BP)
|
Phase 3 | |
| Not yet recruiting |
NCT04128176 -
Efficacy and Safety of Rituximab Combined With Omalizumab in Patients With Bullous Pemphigoid
|
Phase 3 | |
| Recruiting |
NCT05284929 -
Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
|
||
| Terminated |
NCT04612790 -
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
|
Phase 3 | |
| Completed |
NCT00286325 -
Rituximab in the Treatment of Patients With Bullous Pemphigoid
|
Phase 1/Phase 2 | |
| Completed |
NCT04728854 -
Telederm and Bullous Pemphigoid
|
||
| Completed |
NCT04117932 -
Efficacy and Safety of Ustekinumab in Bullous Pemphigoid
|
Phase 2 |