Alopecia Areata (AA)Phase 2NCT02197455
Tofacitnib for the Treatment of Alopecia Areata and Variants
A Phase 2 study testing Tofacitinib Administration in people with Alopecia Areata (AA) and Alopecia Totalis (AT), run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Alopecia Areata (AA), Alopecia Totalis (AT), Alopecia Universalis (AU)
- What is being tested?
- Tofacitinib Administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
- Hair loss present for at least 6 months
- No treatment for alopecia areata in past 2 months
- No evidence of hair regrowth
- Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
Who cannot join
- Age <18 years old
- Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
- Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
- Patients known to be HIV or hepatitis B or C positive
- Patients with positive tuberculin skin test or positive QuantiFERON TB test
- Patients with leukopenia or anemia
Show all 11Show fewer
- Patients with renal or hepatic impairment
- Patients with peptic ulcer disease
- Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
- Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.
Read the detailed description
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.
- Being tested
- Tofacitinib Administration
- Medical subject headings
- Alopecia Areata, Alopecia universalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib AdministrationDrug
5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib Administration | Experimental | 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. Receives: Drug: Tofacitinib Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Severity of Alopecia Tool (SALT) Score
SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
Measured: 3 months
Secondary outcomes (1)
Mean Change in Skindex 16 Scores
Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alopecia Areata (AA)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brett King, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197455
- Sponsor's protocol ID
- 1407014260
- Status last verified
- Mar 2017
- First submitted
- 18 Jul 2014
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.
PubMed 27699252
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tofacitnib for the Treatment of Alopecia Areata and Variants
- ClinicalTrials.gov ID
- NCT02197455
- Acronym / sponsor ID
- 1407014260
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.
Detailed description
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib Administration | Experimental | Drug: Tofacitinib Administration5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >= 18 years old
- Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
- Hair loss present for at least 6 months
- No treatment for alopecia areata in past 2 months
- No evidence of hair regrowth
Key exclusion criteria (11 listed)
- Age <18 years old
- Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
- Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
- Patients known to be HIV or hepatitis B or C positive
- Patients with positive tuberculin skin test or positive QuantiFERON TB test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib Administration5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. | Drug | Tofacitinib Administration |
Primary outcome
Mean Change in Severity of Alopecia Tool (SALT) Score
Time frame: 3 months
SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
1 secondary outcome
Mean Change in Skindex 16 Scores
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27699252Kennedy Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge MC, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight. 2016 Sep 22;1(15):e89776. doi: 10.1172/jci.insight.89776.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett King, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib Administration in people with Alopecia Areata (AA) and Alopecia Totalis (AT), run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Severity of Alopecia Tool (SALT) Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.