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A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01316601
Enrollment
3
Registered
2011-03-16
Start date
2011-01-31
Completion date
2012-11-30
Last updated
2015-05-28

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

Conditions

Crohn's Disease

Brief summary

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas * Trial with medicinal product

Interventions

DRUGQAX567

Sponsors

Novartis Pharmaceuticals
CollaboratorINDUSTRY
Gerhard Rogler
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- diagnosis of Crohn's disease \> 6 month with fistula - at least 1 ineffective fistula treatment in the past

Exclusion criteria

- TNF a antibody treatment failed in the past \- planned surgery

Design outcomes

Primary

MeasureTime frame
complete closure of fistula

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026