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Janus Kinase (JAK) Inhibitor

Tofacitinib for Immune Skin Conditions in Down Syndrome

Phase 2
Recruiting
Led By Joaquin Espinosa, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate-to-severe hidradenitis suppurativa
Moderate-to-severe vitiligo.
Must not have
Kidney transplant within the last two years
Any history of lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 18
Awards & highlights

Summary

This trial tests if a drug that blocks interferon signaling is safe and effective in people with Down syndrome and an autoimmune or autoinflammatory skin condition.

Who is the study for?
This trial is for adolescents and adults with Down syndrome, aged 12-50 years, weighing at least 40 kg, who have moderate-to-severe immune skin conditions like psoriasis or eczema. Participants must avoid pregnancy or fathering children and need a study partner or legal guardian to assist with the study.Check my eligibility
What is being tested?
The trial tests Tofacitinib's safety and effectiveness in improving skin conditions associated with increased interferon signaling in individuals with Down syndrome. It also examines the drug's impact on molecular markers, cognitive abilities, and quality of life.See study design
What are the potential side effects?
Potential side effects of Tofacitinib may include infections due to weakened immune response, digestive issues, headaches, respiratory tract infections, high blood pressure, and increases in cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate-to-severe skin condition with painful lumps.
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I have moderate to severe vitiligo.
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I have moderate-to-severe eczema.
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I have lost at least 25% of my hair.
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I am between 12 and 50 years old, have Down syndrome, and weigh at least 40 kg.
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I have moderate to severe psoriasis.
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I am between 12 and 50 years old, have Down syndrome, and weigh at least 40 kg.
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I have a severe skin condition like eczema, psoriasis, or vitiligo.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a kidney transplant within the last two years.
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I have a history of lymphoma.
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I am unable to give my own consent for the trial.
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I weigh less than 40 kg.
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I am not taking other immunosuppressants or specific enzyme affecting drugs.
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I have had a heart attack or stroke in the past.
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I have not had IV antibiotics in the last 3 months.
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I do not have any significant ongoing or chronic viral infections like HIV or hepatitis.
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I have a history of blood clots.
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I have severe kidney problems.
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I have had cancer in the past 5 years or it has come back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Interferon (IFN) Scores in the Transcriptome of White Blood Cells
Safety as Assessed by Number of Serious Adverse Events (SAE)
Secondary outcome measures
A composite score generated using the Meso Scale Discovery (MSD) platform used to assess inflammatory changes in plasma.
Change in Dermatology Life Quality Index (DLQI)
Change in Eczema Area and Severity Index (EASI) Score in Participants with Atopic Dermatitis
+5 more

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552
12%
Nasopharyngitis
1%
Anaemia
1%
Interstitial lung disease
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Immediate Release (IR)
Tofacitinib Modified Release (MR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: On TreatmentExperimental Treatment1 Intervention
Tofacitinib 5mg oral tablets twice daily for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 3
~39970

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,213 Total Patients Enrolled
8 Trials studying Down Syndrome
3,571 Patients Enrolled for Down Syndrome
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
488 Previous Clinical Trials
1,088,370 Total Patients Enrolled
Joaquin Espinosa, PhDPrincipal InvestigatorLinda Crnic Institute, University of Colorado Anschutz Medical Campus
4 Previous Clinical Trials
2,566 Total Patients Enrolled
2 Trials studying Down Syndrome
2,566 Patients Enrolled for Down Syndrome

Media Library

Tofacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04246372 — Phase 2
Down Syndrome Research Study Groups: On Treatment
Down Syndrome Clinical Trial 2023: Tofacitinib Highlights & Side Effects. Trial Name: NCT04246372 — Phase 2
Tofacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246372 — Phase 2
~0 spots leftby Aug 2024
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