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Monoclonal Antibody

Ustekinumab for Gum Inflammation in LAD1

Phase 1 & 2

Recruiting

Led By Beatriz E Marciano, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-65 years

Molecularly and cellularly confirmed LAD1 with inflammatory lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 months

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of the drug ustekinumab in treating gum inflammation in people with LAD1.

Who is the study for?

This trial is for people aged 12-65 with LAD1, a condition affecting white blood cells leading to severe gum inflammation and frequent infections. Participants must use effective contraception if applicable, be willing to provide samples for research, and give informed consent. Those with allergies to ustekinumab components or certain infections/vaccinations, pregnant or breastfeeding individuals, or those with recent malignancies are excluded.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of ustekinumab in treating gum inflammation in LAD1 patients. Over 52 weeks, participants will receive injections of the drug under their skin during visits that include various health exams and biopsies to monitor effects.See study design

What are the potential side effects?

Potential side effects from ustekinumab may include allergic reactions due to its ingredients; however specific side effects related to this trial aren't listed but can generally range from injection site reactions to flu-like symptoms based on how similar drugs affect other conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 65 years old.

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My LAD1 diagnosis is confirmed with tests showing inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the safety and tolerability of ustekinumab in treating LAD1 affected patients who have inflammation, such as gingival, skin or gut.

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Urinary tract infection

Anxiety

Back pain

Dizziness

Fracture

Skin and subcutaneous tissue disorders

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

treatment with ustekinumab based on weight

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2013

Completed Phase 4

~4140

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,461 Total Patients Enrolled

Beatriz E Marciano, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

Media Library

Ustekinumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03366142 — Phase 1 & 2

Coronary Artery Disease Research Study Groups: Single Arm

Coronary Artery Disease Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT03366142 — Phase 1 & 2

Ustekinumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03366142 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have taken part in this research thus far?

"Affirmative. As per the clinicaltrials.gov page, this trial is presently recruiting patients and was first uploaded to the website on July 2nd 2018. The most recent edit occurred on July 9th 2022 and requires 20 participants from a single medical centre."

Answered by AI

Is enrollment for this experiment ongoing?

"As per the clinicaltrials.gov platform, this medical trial is currently recruiting participants. It was initially posted on July 2nd 2018 and has been revised as recently as July 9th 2022."

Answered by AI

Is eligibility for this medical trial restricted to individuals under 45 years of age?

"The minimum age for inclusion in this study is 12, with the cutoff being 65. Additionally, there are twelve additional studies available to those younger than 18 and twenty-seven trials that pertain to individuals above the age of sixty-five."

Answered by AI

What criteria must be met in order to participate in this experiment?

"This medical trial is accepting 20 participants aged between 12 and 65 with a diagnosis of lad1. Eligible patients must be in stable, long-term monogamous relationships free from any potential pregnancy risk as assessed by the principal investigator; have consented to storing biological samples for future research; use an intrauterine device or equivalent, have had a hysterectomy and/or bilateral tubal ligation or both ovaries removed."

Answered by AI

What health conditions does Ustekinumab primarily address?

"Ustekinumab is the drug of choice for those looking to treat adrenal cortex hormones. Additionally, it can be employed in cases where a patient has not responded positively to one or more TNF antagonist therapies, psoriasis, and severe active Crohn's disease."

Answered by AI

What prior research has been conducted regarding the efficacy of Ustekinumab?

"Currently, there are 34 studies investigating Ustekinumab with 17 trials in their final stage. The majority of these clinical tests are based out of Gdansk, Pomorskie yet 2820 different sites have hosted them at some point."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology

2018. "Ustekinumab (Anti-IL-12/23p40 Monoclonal Antibody) in Patients With Leukocyte Adhesion Deficiency Type 1 (LAD1) Who Have Inflammatory Pathology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03366142.

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