Alopecia AreataNCT06573593
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
An observational study of Alopecia Areata and Janus Kinase Inhibitors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Alopecia Areata, Janus Kinase Inhibitors
- What is being tested?
- Tofacitinib, Baricitinib and Ruxolitinib
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine
Who may be able to join
- Patients with alopecia areata between 2 to 18 years old
- Patients diagnosed with alopecia areata according to AA guideline
- AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months
Who cannot join
- Patients had previously received hair implants
- Other alopecia
- Other diseases may induce alopecia including psoriasis, lichen planus, et al.
- Unable to estimate SALT score at baseline or at follow-up
- Patients are participating in other clinical trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wu contact
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Ru Dai, Ph.D, 86 15982215914, dairu@zju.edu.cn
About this study
Official title: Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.
- Conditions
- Alopecia Areata, Janus Kinase Inhibitors
- Being tested
- Tofacitinib, Baricitinib, Ruxolitinib, Upadacitinib, Abrocitinib
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
In the real-world settings, patients with AA treated with tofacitinib.
BaricitinibDrug
In the real-world settings, patients with AA treated with Baricitinib.
RuxolitinibDrug
In the real-world settings, patients with AA treated with Ruxolitinib.
UpadacitinibDrug
In the real-world settings, patients with AA treated with Upadacitinib.
AbrocitinibDrug
In the real-world settings, patients with AA treated with Abrocitinib.
RitlecitinibDrug
In the real-world settings, patients with AA treated with Ritlecitinib.
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib treated group | In the real-world settings, patients with AA treated with tofacitinib. Receives: Drug: Tofacitinib | |
| Baritinib treated group | In the real-world settings, patients with AA treated with baritinib. Receives: Drug: Baricitinib | |
| Ruxolitinib treated group | In the real-world settings, patients with AA treated with ruxolitinib Receives: Drug: Ruxolitinib | |
| Upadacitinib treated group | In the real-world settings, patients with AA treated with upadacitinib. Receives: Drug: Upadacitinib | |
| Abrocitinib treated group | In the real-world settings, patients with AA treated with abhicitinib. Receives: Drug: Abrocitinib | |
| Ritlecitinib treated group | In the real-world settings, patients with AA treated with ritlecitinib. Receives: Drug: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean SALT
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
Measured: at week 24
SALT50
Percentage of patient with more than 50% improvement in SALT score
Measured: at week 24
SALT75
Percentage of patient with more than 70% improvement in SALT score
Measured: at week 24
Secondary outcomes (4)
Mean SALT
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
Measured: at week 12, 36, 48, 56
SALT50
Percentage of patient with more than 75% improvement in SALT score
Measured: at week 12, 36, 48, 56
SALT75
Percentage of patient with more than 50% improvement in SALT score
Measured: at week 12, 36, 48, 56
Safety profile
Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events.
Measured: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianjie Wu, Ph.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573593
- Sponsor's protocol ID
- 20240699
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study
- ClinicalTrials.gov ID
- NCT06573593
- Acronym / sponsor ID
- 20240699
- Conditions
- Alopecia Areata, Janus Kinase Inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib treated group | – | Drug: TofacitinibIn the real-world settings, patients with AA treated with tofacitinib. |
| Baritinib treated group | – | Drug: BaricitinibIn the real-world settings, patients with AA treated with baritinib. |
| Ruxolitinib treated group | – | Drug: RuxolitinibIn the real-world settings, patients with AA treated with ruxolitinib |
| Upadacitinib treated group | – | Drug: UpadacitinibIn the real-world settings, patients with AA treated with upadacitinib. |
| Abrocitinib treated group | – | Drug: AbrocitinibIn the real-world settings, patients with AA treated with abhicitinib. |
| Ritlecitinib treated group | – | Drug: RitlecitinibIn the real-world settings, patients with AA treated with ritlecitinib. |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine
Key inclusion criteria (3 listed)
- Patients with alopecia areata between 2 to 18 years old
- Patients diagnosed with alopecia areata according to AA guideline
- AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months
Key exclusion criteria (5 listed)
- Patients had previously received hair implants
- Other alopecia
- Other diseases may induce alopecia including psoriasis, lichen planus, et al.
- Unable to estimate SALT score at baseline or at follow-up
- Patients are participating in other clinical trials
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 |
|---|---|---|
| TofacitinibIn the real-world settings, patients with AA treated with tofacitinib. | Drug | Tofacitinib treated group |
| BaricitinibIn the real-world settings, patients with AA treated with Baricitinib. | Drug | Baritinib treated group |
| RuxolitinibIn the real-world settings, patients with AA treated with Ruxolitinib. | Drug | Ruxolitinib treated group |
| UpadacitinibIn the real-world settings, patients with AA treated with Upadacitinib. | Drug | Upadacitinib treated group |
| AbrocitinibIn the real-world settings, patients with AA treated with Abrocitinib. | Drug | Abrocitinib treated group |
| RitlecitinibIn the real-world settings, patients with AA treated with Ritlecitinib. | Drug | Ritlecitinib treated group |
Primary outcome
Mean SALT
Time frame: at week 24
Reduction of Severity of Alopecia Tool (SALT) score compared with baseline
SALT50
Time frame: at week 24
Percentage of patient with more than 50% improvement in SALT score
SALT75
Time frame: at week 24
Percentage of patient with more than 70% improvement in SALT score
4 secondary outcomes
Mean SALT
Time frame: at week 12, 36, 48, 56
SALT50
Time frame: at week 12, 36, 48, 56
SALT75
Time frame: at week 12, 36, 48, 56
Safety profile
Time frame: at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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.
Wu contact
Xianjie Wu, Ph.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia Areata and Janus Kinase Inhibitors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Aug 2024. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ru Dai, MD (15982215914, dairu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean SALT (time frame: at week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.