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Metadata

Name
Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT03366142
Description
Background:

The disease leukocyte adhesion deficiency type 1 (LAD1) affects white blood cells. Those are
immune system cells. In people with LAD1, white blood cells do not properly communicate with
the rest of the body. This causes uncontrolled inflammation, particularly in the gums. People
with LAD1 can get frequent infections and tend to lose their teeth before adulthood.
Researchers want to see if a drug called ustekinumab helps people with LAD1.

Objective:

To study the safety and tolerability of ustekinumab in treating gum inflammation in people
with LAD1.

Eligibility:

People ages 12 65 with LAD1

Design:

Participants will be screened with:

- Medical history

- Physical exam

- Oral exam

- A scan of the chest, abdomen, and pelvis for possible infection

- Blood and urine tests

The baseline visit will take 2 days. Participants will:

- Repeat most screening tests

- Have a skin exam

- Have small pieces of their gums removed (biopsy)

- Have mouth fluids collected

- Get the study drug injected under the skin of the abdomen, thigh, or elsewhere on the
body. They will be watched for at least 2 hours.

Participants will be instructed on tracking how they are feeling and any side effects.

Participants will have 4 more visits over 40 weeks. They will get the study drug and repeat
the baseline tests.

Participants may have up to 5 more tissue biopsies.

Participants will be called between visits to discuss how they are feeling and side effects.

Participants will have a final visit 52 weeks after the baseline. They will repeat most of
the baseline tests.

Participants will answer questions about their oral ulcers.
Data or Study Types
clinical trial
Keywords
Gingival, Autosomal Recessive Disorder, Oral Ulcer, Cytokine Expression, Immune
Source Organization
Unknown
Access Conditions
available
Year
2017
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT03366142

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