Study of efficacy, safety and blood-related changes of QGE031 in bullous pemphigoid patients not responding adequately to oral steroid treatment

A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222213

Enrollment

Registered

2013-09-04

Start date

2013-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bullous pemphigoid

Interventions

investigational material(s) Generic name etc : QGE031 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patients diagnosed with bullous pemphigoid *Stable dose of prednisone at or above 10 mg per day but no greater than 1 mg/kg/day *Weigh between 40-120kg *Total IgE level up to 5000 IU/mL Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion criteria: *Use of rituximab within 1 year Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Change in the Clinical Global Assessment of Change from Baseline to Week 12	—

Secondary

Measure	Time frame
Change in the Clinical Global Assessment of Change from Baseline to Week 6 Change from baseline in the Investigator Global Assessment over 48 weeks Safety of QGE031 over 48 weeks	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026