Atopic DermatitisPhase 3NCT05676242
A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
A Phase 3 study testing Jaktinib Hydrochloride Tablet in people with Atopic Dermatitis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites in China.
Trial summary
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Jaktinib Hydrochloride Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 2 sitesChina
- Study dates
- 11 Jan 2023to 12 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigator thinks that the subject can continue to benefit from participating in the extension trial;
- Fully understand the extension trial and sign the informed consent form;
- Complete the ZGJAK025 trial for 16 weeks and have good compliance;
- It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;
Who cannot join
- Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
- The investigator thinks that the subject is not suitable for the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjin, Jiangsu
About this study
Official title: A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
Read the detailed description
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.
- Conditions
- Atopic Dermatitis
- Being tested
- Jaktinib Hydrochloride Tablet
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Hydrochloride TabletDrug
Orally administered, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 100mg BID | Experimental | Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day Receives: Drug: Jaktinib Hydrochloride Tablet |
| Jaktinib 75mg BID | Experimental | Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day Receives: Drug: Jaktinib Hydrochloride Tablet |
| Placebo | Placebo comparator | Drug: Placebo Orally administered, twice a day Receives: Drug: Jaktinib Hydrochloride Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects with treatment emergent adverse event (TEAE)
Safety of the drug
Measured: 36 weeks after the first dose
Number and percentage of subjects with Serious Adverse Event (SAE)
Safety of the drug
Measured: 36 weeks after the first dose
Secondary outcomes (3)
The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline
The proportion of subjects who reached EASI-75
Measured: 36 weeks after the first dose
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline
The proportion of subjects who reached IGA 0/1
Measured: 36 weeks after the first dose
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline
The proportion of subjects who reached NRS4
Measured: 36 weeks after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start11 Jan 2023
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Wu, Study chair, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676242
- Sponsor's protocol ID
- ZGJAK026
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2022
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05676242
- Acronym / sponsor ID
- ZGJAK026
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 9 Jan 2023 (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.
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
Detailed description
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 100mg BID | Experimental | Drug: Jaktinib Hydrochloride TabletDrug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day |
| Jaktinib 75mg BID | Experimental | Drug: Jaktinib Hydrochloride TabletDrug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day |
| Placebo | Placebo comparator | Drug: Jaktinib Hydrochloride TabletDrug: Placebo Orally administered, twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The investigator thinks that the subject can continue to benefit from participating in the extension trial;
- Fully understand the extension trial and sign the informed consent form;
- Complete the ZGJAK025 trial for 16 weeks and have good compliance;
- It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;
Key exclusion criteria (2 listed)
- Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
- The investigator thinks that the subject is not suitable for the trial.
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 |
|---|---|---|
| Jaktinib Hydrochloride TabletOrally administered, twice a day | Drug | Jaktinib 100mg BID, Jaktinib 75mg BID, Placebo |
Primary outcome
Number and percentage of subjects with treatment emergent adverse event (TEAE)
Time frame: 36 weeks after the first dose
Safety of the drug
Number and percentage of subjects with Serious Adverse Event (SAE)
Time frame: 36 weeks after the first dose
Safety of the drug
3 secondary outcomes
The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline
Time frame: 36 weeks after the first dose
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline
Time frame: 36 weeks after the first dose
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline
Time frame: 36 weeks after the first dose
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 3 Nov 2026.
- 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.
Jason Wu study chair
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
2 sites 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 Hydrochloride Tablet in people with Atopic Dermatitis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites 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 4 inclusion and 2 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 and percentage of subjects with treatment emergent adverse event (TEAE) (time frame: 36 weeks after the first dose). The study lists 2 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 3 Nov 2026.