Study 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.
Eligible Conditions
- Down Syndrome
- Hidradenitis Suppurativa
- Psoriasis
- Eczema
- Vitiligo
- Alopecia Areata
Treatment Effectiveness
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Up to Week 18
Baseline and 16 weeks
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
Change in Interferon (IFN) Scores in the Transcriptome of White Blood Cells
Change in Investigator's Global Assessment (IGA)
Change in Modified Sartorius Score (MSS) Score in Participants with Hidradenitis Suppurativa
Change in Psoriasis Area and Severity Index (PASI) Score in Participants with Psoriasis
Change in Severity of Alopecia Tool (SALT) Score in Participants with Alopecia
Change in Vitiligo Extent Tensity Index (VETI) in Participants with Vitiligo
Up to Week 18
Safety as Assessed by Number of Serious Adverse Events (SAE)
Trial Safety
Side Effects for
Tofacitinib
47%Dyslipidemia
32%Upper respiratory tract infection
11%Acne
5%Constipation
5%Myalgia
5%Intestinal tuberculosis
5%Weight gain
Trial Design
1 Treatment Group
On Treatment
1 of 1
Experimental Treatment
47 Total Participants · 1 Treatment Group
Primary Treatment: Tofacitinib · No Placebo Group · Phase 2
On Treatment
Drug
Experimental Group · 1 Intervention: Tofacitinib · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 18
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
447 Previous Clinical Trials
1,072,413 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,591 Previous Clinical Trials
1,927,216 Total Patients Enrolled
8 Trials studying Down Syndrome
2,571 Patients Enrolled for Down Syndrome
Cory Dunnick, MDPrincipal InvestigatorDepartment of Dermatology, University of Colorado Anschutz Medical Campus
2 Previous Clinical Trials
116 Total Patients Enrolled
David Norris, MDPrincipal InvestigatorDepartment of Dermatology, University of Colorado Anschutz Medical Campus
Joaquin Espinosa, PhDPrincipal InvestigatorLinda Crnic Institute, University of Colorado Anschutz Medical Campus
4 Previous Clinical Trials
1,566 Total Patients Enrolled
2 Trials studying Down Syndrome
1,566 Patients Enrolled for Down Syndrome
Eligibility Criteria
Age 12 - 50 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have moderate-to-severe atopic dermatitis.
You have moderate-to-severe psoriasis.
You must be at least 18 years old to complete this study.
Who else is applying?
What state do they live in?
| Tennessee | 50.0% |
| California | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 25.0% |
| Did not meet criteria | 75.0% |
What site did they apply to?
| Linda Crnic Institute for Down Syndrome | 100.0% |
References
- Rachubinski, Angela L., Belinda Enriquez Estrada, David Norris, Cory A. Dunnick, Jennifer C. Boldrick, and Joaquin M. Espinosa. 2019. “Janus Kinase Inhibition in down Syndrome: 2 Cases of Therapeutic Benefit for Alopecia Areata”. JAAD Case Reports. Elsevier BV. doi:10.1016/j.jdcr.2019.02.007.
- Pham, Andrew T., Angela L. Rachubinski, Belinda Enriquez-Estrada, Kayleigh Worek, Melissa Griffith, and Joaquin M. Espinosa. 2021. “JAK Inhibition for Treatment of Psoriatic Arthritis in down Syndrome”. Rheumatology. Oxford University Press (OUP). doi:10.1093/rheumatology/keab203.
- Rachubinski AL, Estrada BE, Norris D, Dunnick CA, Boldrick JC, Espinosa JM. Janus kinase inhibition in Down syndrome: 2 cases of therapeutic benefit for alopecia areata. JAAD Case Rep. 2019 Apr 5;5(4):365-367. doi: 10.1016/j.jdcr.2019.02.007. eCollection 2019 Apr. No abstract available.
- Pham AT, Rachubinski AL, Enriquez-Estrada B, Worek K, Griffith M, Espinosa JM. JAK inhibition for treatment of psoriatic arthritis in Down syndrome. Rheumatology (Oxford). 2021 Sep 1;60(9):e309-e311. doi: 10.1093/rheumatology/keab203. No abstract available.
- 2020. "Tofacitinib for Immune Skin Conditions in Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04246372.
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Conditions
Cancer Related
Treatments