NCT01995747

Brief Summary

Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be effective for patients with much higher serum IgE levels, such as those with atopic dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

November 21, 2013

Last Update Submit

November 26, 2013

Conditions

Atopic Dermatitis

Keywords

IgEAtopic Dermatitisantibodyallergy

Outcome Measures

Primary Outcomes (1)

  • IgE

    mesure IgE production in PBMC culture supernatant

    Day 14

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of atopic dermatisis

You may qualify if:

  • Male and female subjects aged ≥ 18 years
  • Clinical diagnosis of atopic dermatitis or chronic urticaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, AtopicHypersensitivity

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateImmune System Diseases

Study Officials

  • Chia-Yu Chu, M.D., Ph.D.

    Dept of Dermatology, NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 27, 2013

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

TW(1)