Could a common arthritis drug ease skin woes in down syndrome?
NCT ID NCT04246372
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether tofacitinib, a drug already approved for arthritis, is safe and helpful for immune-related skin conditions in people with Down syndrome. 47 adolescents and adults with Down syndrome and skin issues like eczema or psoriasis took the drug. Researchers checked for side effects and measured changes in skin symptoms and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tofacitinib (Xeljanz), an oral drug that blocks interferon signaling
- What this could lead to
- If successful, this could point toward a treatment for skin conditions like eczema or psoriasis in people with Down syndrome.
- What could go wrong
- This is a small, early-phase trial with only 47 participants. The drug may not work for all skin conditions, and serious side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
47 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Oct 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males or females with DS between 12 and 50 years of age who weigh at least 40 kg. * Diagnosis of at least one active immune skin condition, including but not limited to: 1. Moderate-to-severe atopic dermatitis 2. Alopecia areata affecting at least 25% of the scalp 3. Moderate-to-severe hidradenitis suppurativa 4. Moderate-to-severe psoriasis 5. Moderate-to-severe vitiligo. * Be willing to avoid pregnancy or fathering children. * Must present with a study partner or legal guardian who can complete, or assist with completing, study materials as appropriate. Exclusion Criteria * Weigh less than 40 kg. * Pregnancy or breast feeding. * No study partner or legal guardian. * Vaccination with live attenuated virus within six weeks of inclusion in the study or planned during the study. * Clinically significant chronic or active viral infection including but not limited to HIV, hepatitis, CMV, EBV, HSV. * Severe renal impairment. * History of malignant solid tumor cancer within five years prior to study entry or where there is current evidence of recurrent or metastatic disease. * Poor venous access not allowing repeated blood tests or non-compliance with venipuncture requirements. * Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment. * Concomitant treatment with other immunosuppressants (e.g. corticosteroids, methotrexate) or strong CP3A4 or CYP2C19 inhibitors or inducers (e.g. ketoconazole, fluconazole). * Known allergies, hypersensitivity, or intolerance to Tofacitinib. * History of thrombotic disorder. * Superficial skin infection within 2 weeks of inclusion in the study. * History of disseminated herpes zoster, disseminated herpes simplex, or recurrent localized dermatomal herpes zoster. * Intravenous antimicrobial therapy within 3 months of inclusion in the study. * Oral antimicrobials within 2 weeks of inclusion in the study. * Participants may be excluded for other unforeseen reasons at the study doctor's discretion. * Unable to provide assent in cases where informed consent is obtained from other authorized representative. * Kidney transplant within the last two years * Any history of heart attack or stroke. * Any history of lymphoma. * Past or current smokers.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Linda Crnic Institute for Down Syndrome
Aurora, Colorado, 80045, United States
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