Alopecia AreataPhase 3AANCT05255237
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata
A Phase 3 study testing Jaktinib in people with Alopecia Areata, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design". Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Jaktinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2022to 28 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily sign the informed consent form.
- Patients who participated in ZGJAK018.
Who cannot join
- Subjects who are unsuitable to the trial, as identified by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Adult Patients With Moderate to Severe Alopecia Areata
This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design".
- Conditions
- Alopecia Areata
- Being tested
- Jaktinib
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JaktinibDrug
75mg BID
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib | Experimental | Patients will administer the study product twice per day for 24 weeks, for the safety assessment. Receives: Drug: Jaktinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reporting treatment-emergent adverse events
Patients with treatment-emergent adverse events/all patients *100%
Measured: Baseline through week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start25 Mar 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
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 Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, PhD, Principal investigator, Peking University People's HospitalQianjin Lu, PhD, Principal investigator, Hospital for skin diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255237
- Sponsor's protocol ID
- ZGJAK020
- Acronym
- AA
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Adult Patients With Moderate to Severe Alopecia Areata
- ClinicalTrials.gov ID
- NCT05255237
- Acronym / sponsor ID
- AA / ZGJAK020
- Conditions
- Alopecia Areata
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 24 Feb 2022 (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.
This study (Unique Protocol ID: ZGJAK020) as an extension of the ongoing "Study to Evaluate Safety and Efficacy of Jaktinib in Adults With Alopecia Areata (Unique Protocol ID:ZGJAK020)" study. After completion of ZGJAK018 study, the study will be directly extend with an "open-label design".
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jaktinib | Experimental | Drug: JaktinibPatients will administer the study product twice per day for 24 weeks, for the safety assessment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects voluntarily sign the informed consent form.
- Patients who participated in ZGJAK018.
Key exclusion criteria (1 listed)
- Subjects who are unsuitable to the trial, as identified by the investigator.
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 |
|---|---|---|
| Jaktinib75mg BID | Drug | Jaktinib |
Primary outcome
Number of subjects reporting treatment-emergent adverse events
Time frame: Baseline through week 24
Patients with treatment-emergent adverse events/all patients *100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
Jianzhong Zhang, PhD principal investigator
Peking University People's Hospital
Qianjin Lu, PhD principal investigator
Hospital for skin diseases, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jaktinib in people with Alopecia Areata, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd 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 2 inclusion and 1 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 18 Mar 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects reporting treatment-emergent adverse events (time frame: Baseline through week 24). 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 18 Mar 2025.