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Impact of omalizumab withdrawal after a 3 year duration treatment in well controlled severe allergic asthma : a multicentric randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2020-000883-42-FR
Enrollment
234
Registered
2020-08-05
Start date
2021-01-18
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

well controlled severe allergic asthma MedDRA version: 21.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855

Interventions

Trade Name: XOLAIR Product Name: XOLAIR Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: OMALIZUMAB CAS Number: 242138-07-4 Concentration unit: mg milligram(s) Co

Sponsors

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: NA 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 234 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 234

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

MeasureTime frame
Main Objective: NA;Secondary Objective: NA;Primary end point(s): NA;Timepoint(s) of evaluation of this end point: NA—

Secondary

MeasureTime frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA—

Countries

France

Contacts

Public ContactYannick VACHER

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

yannick.vacher@aphp.fr33144.84.17.30

Outcome results

None listed

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