A Phase II Efficacy Study in Fistulizing Crohn's Disease Patients

A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019973-13-DE

Enrollment

Registered

2010-09-30

Start date

2011-01-14

Completion date

Unknown

Last updated

2012-09-03

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

Conditions

Treatment of perianal fistulas in patients suffering from Crohn's Disease. MedDRA version: 14.0 Level: PT Classification code 10016717 Term: Fistula System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Code: QAX576 Pharmaceutical Form: Powder and solvent for solution for infusion Current Sponsor code: QAX576 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • At least one draining enterocutaneous perianal fistula • Diagnosis of Crohn's disease (CD) must have been established for at least 6 months • At least one ineffective fistula treatment (but no previously failed anti- TNFa (tumour necrosis factor) antibody treatment) • Patients should not suffer from any other health problems that may jeopardize their participation in the study. Additional details and inclusion criteria are available in the clinical study protocol. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Current or recent (within 30 days of enrollment, or 5 half-lives of the compound, whichever is longer) use of anti-TNFa antibody treatment • Active Crohn's disease • Recent or pending abdominal or ano-rectal surgery, particularly presence of stricture, or abscess, or retention for which surgery might be indicated • Previously failed anti-TNFa antibody treatment • Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed) Additional details and exclusion criteria are available in the clinical study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: • Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ];Secondary Objective: • Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Other secondary objectives are listed in the clinical study protocol.;Primary end point(s): • Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Main Objective: • Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation [ Time Frame: 52 weeks ] [ Designated as safety issue: No ];Secondary Objective: • Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ] Other secondary objectives are listed in the clinical study protocol.;Primary end point(s): • Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation;Timepoint(s) of evaluation of this end point: 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): •Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc;Timepoint(s) of evaluation of this end point: 52 weeks	—

Countries

Germany, Switzerland

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

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