Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00024544

Enrollment

120

Registered

2001-09-20

Start date

2001-08-31

Completion date

2003-02-28

Last updated

2012-03-07

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

Conditions

Asthma

Keywords

asthma, anti-IL-4 monoclonal antibody, pascolizumab

Brief summary

The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

Interventions

DRUGanti-IL-4 monoclonal antibody (pascolizumab)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* At least a 6-month history of asthma * No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment

Exclusion criteria

* Patients with \> 10 pack years of smoking history or smoking within 12 months of study enrollment * No significant disease other than asthma

Countries

United States

Outcome results

None listed

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