Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite 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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003370-10-AT

Enrollment

Registered

2012-10-03

Start date

2012-11-13

Completion date

Unknown

Last updated

2015-07-10

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

Conditions

Refractory Bullous Pemphigoid MedDRA version: 15.0 Level: LLT Classification code 10006567 Term: Bullous pemphigoid System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Code: QGE031 Pharmaceutical Form: Concentrate for solution for injection/infusion Current Sponsor code: QGE031 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients diagnosed with bullous phemphigoid - Stable dose of prednisone at or above 10mg per day but no greather than 1mg/kg/day - Weight between 40-120kg - Total IgE level up to 5000 IU/mL listing incomplete, additional inclusion criteria applicable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: - Use of rifuximab within 1 year listing incomplete, additional exclusion criteria applicable

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of QGE031 240mg q2w relative to placebo at 12 weeks in patients with BP by reducing disease activity as determined by Clinical Global Assessment of Change (CGA-C) responder rate.;Secondary Objective: 1.To evaluate the CGA-C responder rate in QGE031 240mg q2w vs. Placebo treated patients at 6 weeks 2.To evaluate the effect of QGE031 240mg q2w in BP patients as assessed by Investigator Global Assessment (IGA) 3.To evaluate the safety of QGE031 in BP patients ;Primary end point(s): Change in the Clinical Global Assessment of change from baseline to week 12.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of QGE031 240mg q2w relative to placebo at 12 weeks in patients with BP by reducing disease activity as determined by Clinical Global Assessment of Change (CGA-C) responder rate.;Secondary Objective: 1.To evaluate the CGA-C responder rate in QGE031 240mg q2w vs. Placebo treated patients at 6 weeks 2.To evaluate the effect of QGE031 240mg q2w in BP patients as assessed by Investigator Global Assessment (IGA) 3.To evaluate the safety of QGE031 in BP patients ;Primary end point(s): Change in the Clinical Global Assessment of change from baseline to week 12.;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): - 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.;Timepoint(s) of evaluation of this end point: - 6 weeks - baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks - baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks	—

Measure

Time frame

Secondary end point(s): - 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.;Timepoint(s) of evaluation of this end point: - 6 weeks - baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks - baseline, every 2 weeks up to 12 weeks, every 4 weeks up to 24 weeks, every 8 weeks up to 48 weeks

—

Countries

Austria, Germany, Taiwan, United States

Contacts

Public ContactProject Manager at CRO

Assign Clinical Research GmbH

carina.anger@assigngroup.com+431403380544

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026