Omalizumab to Treat Hyper-IgE (Job's) Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00260702
• Date of registration: 01/12/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Omalizumab to Treat Hyper-IgE (Job's) Syndrome
• Scientific title: Pilot Study of Omalizumab (Xolair) in Hyper IgE (Job's) Syndrome
• Date of first enrolment: November 24, 2005
• Target sample size: 1
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00260702
• Study type: Interventional
• Study design: Primary purpose: Treatment.
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

-INCLUSION CRITERIA:

1. All Subjects must be at least 6 years of age and no older than 76 years of age (as per
original safety studies).

2. All subjects must meet the established diagnostic criteria for HIES as determined by
the NIH scoring system, with a score greater than 40, or have a mutation in the STAT3
gene.

3. Baseline values within the following laboratory ranges:

- White blood cell count greater than or equal to 3,300 cells/microliter.

- Absolute neutrophil count greater than or equal to 1,000 cells/microliter.

- Hemoglobin greater than or equal to 10 g/dL.

- Platelet count greater than or equal to 100,000 platelets/micoliter.

4. Women of childbearing potential only: negative urine pregnancy test. Both men and
women and their partners must agree to practice abstinence or effective contraception
from initiation of the protocol and for 2 months following the last dose of the study
drug (effective contraception methods include abstinence, surgical sterilization of
either partner, barrier methods such as diaphragm, condom, cap, or sponge, or hormonal
contraception).

5. Weight (Kg) times serum IgE (IU/mL) less than 3,000,000, then as above greater than
63,000, less than 3,000,000.

6. Patients in tier II must be 16 years or older.

7. Preference will be given to patients with dermatitis.

8. Subjects (guardians for younger patients) must be able to give informed consent (or
assent as appropriate).

9. Subjects must already be signed to other NIH studies on HIES.

10. Subjects must be willing to maintain their current regimens for skin care,
prophylactic antibiotics (if applicable), and any asthma related oral or inhaled
medications. Albuterol rescue medications may be used as needed.

11. Patients participating in protocols at the National Institutes of Health are expected
to have a primary physician outside of the NIH.

EXCLUSION CRITERIA:

1. Pregnant or nursing women.

2. HIV positive diagnosis.

3. Use of any other investigational agent within 30 days of the study.

4. Any condition that, in the investigator's opinion, places the patient at undue risk by
participating in the study.

5. Previous anaphylaxis to the study medication.



Age minimum: 6 Years
Age maximum: 76 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hyper-IgE Syndrome

Job's Syndrome

Intervention(s)

Drug: Omalizumab (Xolair)

Secondary ID(s)

06-I-0032

060032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors