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Could a common arthritis drug ease skin woes in down syndrome?

NCT ID NCT04246372

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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