Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pemphigus Vulgaris

In brief

The study evaluated the efficacy, safety and pharmacokinetics of VAY736 in the treatment of patients with pemphigus vulagaris (PV).

Key facts

Study ID

NCT01930175

Run by

Novartis Pharmaceuticals

People needed

13

Starts

2013-12-18

Expected to finish

2019-09-25

Last updated by the study team

2021-10-08

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients 20 to 70 years of age
• Confirmed diagnosis of pemphigus vulgaris
• Presence of mild to moderate pemphigus vulgaris
• Patients must weight between 40 kg and 150 kg inclusive
• on a stable dose of oral corticosteriod therapy (with or without azathioprine or mycophenolate)

You may not qualify if…

• Pregnant or nursing (lactating) women
• Women of child-bearing potential unless they are using a highly effective method of birth control during dosing and for 4 months following study treatment
• Recent previous treatment with photo therapy, biological therapy, steroids, immunosuppresive agents (unless washout period applied)
• Active or recent history of clinically significant infection
• use of rituximab within 1 year Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Sofia, BGR, Bulgaria
• Novartis Investigative Site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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