A Safety and Dose-Finding Study of SYNT001 in Subjects With Pemphigus (Vulgaris or Foliaceus)
NCT03075904 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2020-02-05
Summary
This was a multicenter, open-label safety study to determine the dose regimen of SYNT001 (ALXN1830) administered intravenously in participants with pemphigus (vulgaris or foliaceus).
Conditions
- Pemphigus
- Pemphigus Vulgaris
- Pemphigus Foliaceus
Interventions
- DRUG
-
ALXN1830
Administered via IV infusion.
Sponsors & Collaborators
-
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-18
- Primary Completion
- 2019-01-16
- Completion
- 2019-01-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
NCT05603195 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
NCT03604692 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS
NCT06903494 ·Status: COMPLETED
-
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06411379 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum
NCT02733094 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
NCT03295383 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases
NCT06342713 ·Status: RECRUITING ·Phase: PHASE1
-
Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
NCT04186559 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
NCT06411899 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Omalizumab in Bullous Pemphigoid
NCT00472030 ·Status: COMPLETED ·Phase: PHASE4
-
Rituximab in the Treatment of Patients With Bullous Pemphigoid
NCT00286325 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus
NCT00483119 ·Status: TERMINATED ·Phase: PHASE2
-
Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease
NCT07113743 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1/PHASE2
-
A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19
NCT04415073 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability, and Bioavailability of Subcutaneously Administered XmAb®7195
NCT02881853 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Safety, Efficacy and Pharmacodynamic Effect of Bertilimumab in Patients With Bullous Pemphigoid
NCT02226146 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Subcutaneous Sonelokimab in Participants With Moderate to Severe Hidradenitis Suppurativa
NCT07007637 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
NCT05681481 ·Status: TERMINATED ·Phase: PHASE3
-
Pilot Efficacy and Safety Study of Oral DF2156A in Patients With Active Bullous Pemphigoid
NCT01571895 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
NCT06419205 ·Status: WITHDRAWN ·Phase: PHASE2
-
Investigation of Otelixizumab in New-Onset, Autoimmune Type 1 Diabetes Mellitus Patients
NCT02000817 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
NCT04256148 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).
NCT06751238 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa
NCT05322473 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus
NCT01974518 ·Status: UNKNOWN ·Phase: PHASE3