Alopecia AreataPhase 2NCT04034134
Study to Evaluate the Safety and Efficacy ofJaktinib Hydrochloride Tablets in Severe Alopecia Areata
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Alopecia Areata, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites in China.
Trial summary
This was an open-label, Multi-center, randomized phase Ⅱ study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Jaktinib Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesChina
- Study dates
- 18 Nov 2019to 26 Nov 2021
- Phase
- Phase 2
- 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
- 18 years age or older ,male or female；
- Alopecia areata diagnosed clinically；
- Patients with alopecia accounting for 50% or more of the total scalp area and stable for at least 6 months or more；
- Patients can complete treatment for at least six months；
- Requirements for pregnant or lactating female and male and female of childbearing age；Female patients must be satisfied：Menopause (defined as no menstruation for at least one year);Or have been surgically sterilized；Or have fertility, but must satisfy：Pregnancy tests conducted within 7 days before randomization must be negative；And agree to use appropriate contraceptive methods throughout the trial period, including at least one barrier method；And no breastfeeding；Male patients must agree to use appropriate contraceptive measures throughout the trial, including at least one barrier method；
- Patients are voluntarily enrolled in the Study and can be treated and visited according to the requirements of the protocol after signing the Informed Consent Form；
Who cannot join
- Alopecia caused by syphilitic alopecia, thyroid disease, trichotilomania, head moss, connective tissue disease, infection, zinc deficiency and iron deficiency;
- Patients with acute diffuse alopecia areata (ADTAFS)
- Patients with active tuberculosis
- The following diseases were combined within 6 months before randomization:thyroid diseases ，liver diseases, malnutrition, heart diseases, nervous system diseases, gastrointestinal disorders, tumors and psychiatric diseases
- HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV-RNA positive at screening；
- Other patients with abnormal history or clinical manifestations that may affect participants participation in the study or may confuse the results of the study；
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- Within two weeks before randomization，Patients who received glucocorticoid topical therapy, anthracene ointment, minoxidil, SADBE/DPCP contact immunotherapy, photochemotherapy or cryotherapy；
- Before randomization，oral or injected any medicines to treat hair loss (including the glucocorticoids was detected in injection, systemic corticosteroids, antihistamines, stephania drugs, glycyrrhizin, glycine, methionine compound tablet, compound glycyrrhizin glucoside) and other liquorice extract, ring spore element, anti TNF antibody, IFN - gamma, IL - 2 antibodies, for alopecia areata therapy of traditional Chinese medicine and other JAK inhibitor) and washout period less than seven half-life of patients;
- Participants in a clinical trial of any drug or medical device within 4 weeks prior to randomization.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The second xaingya hospital of central south university
Changsha, Hunan, 410011
Chongqing Chinese Traditional Medicine Hospital
Chongqing, Chongqing Municipality, 400011
About this study
Official title: A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Severe Alopecia Areata.
This was an open-label, Multi-center, randomized phase Ⅱ study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets.
- Conditions
- Alopecia Areata
- Being tested
- Jaktinib Hydrochloride Tablets
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaktinib Hydrochloride TabletsDrug
50 mg twice-daily (BID)
Jaktinib Hydrochloride TabletsDrug
150 mg quaque die (QD)
Jaktinib Hydrochloride TabletsDrug
200 mg quaque die (QD)
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib Hydrochloride Tablets 50mg bid | Experimental | Oral tablet for 24 weeks Receives: Drug: Jaktinib Hydrochloride Tablets |
| Jaktinib Hydrochloride Tablets 150mg qd | Experimental | Oral tablet for 24 weeks Receives: Drug: Jaktinib Hydrochloride Tablets |
| Jaktinib Hydrochloride Tablets 200mg qd | Experimental | Oral tablet for 24 weeks Receives: Drug: Jaktinib Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate
Effective rate = (cure + obvious effect + effective)/total cases *100%;
Measured: From randomization of the first subject until the last subject complete 6 months treatment
Secondary outcomes (2)
SALT score change
Score and take photos (4 areas on the head), taking photos in the same position and light condition each time;
Measured: From randomization of the first subject until the last subject complete 6 months treatment
Quality of Life (AASIS)
AASIS was used to score the quality of life of the subjects
Measured: From randomization of the first subject until the last subject complete 6 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start18 Nov 2019
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- qianjin Lu, MD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034134
- Sponsor's protocol ID
- ZGJAK003
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2019
- Last updated
- 29 Nov 2022
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study to Evaluate the Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Severe Alopecia Areata.
- ClinicalTrials.gov ID
- NCT04034134
- Acronym / sponsor ID
- ZGJAK003
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 26 Jul 2019 (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 was an open-label, Multi-center, randomized phase Ⅱ study. Patients with severe Alopecia Areata were randomized to receive 50mg bid, 150mg qd or 200 mg qd of oral Jaktinib Hydrochloride Tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaktinib Hydrochloride Tablets 50mg bid | Experimental | Drug: Jaktinib Hydrochloride TabletsOral tablet for 24 weeks |
| Jaktinib Hydrochloride Tablets 150mg qd | Experimental | Drug: Jaktinib Hydrochloride TabletsOral tablet for 24 weeks |
| Jaktinib Hydrochloride Tablets 200mg qd | Experimental | Drug: Jaktinib Hydrochloride TabletsOral tablet for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years age or older ,male or female；
- Alopecia areata diagnosed clinically；
- Patients with alopecia accounting for 50% or more of the total scalp area and stable for at least 6 months or more；
- Patients can complete treatment for at least six months；
- Requirements for pregnant or lactating female and male and female of childbearing age；Female patients must be satisfied：Menopause (defined as no menstruation for at least one year);Or have been surgically sterilized；Or have fertility, but must satisfy：Pregnancy tests conducted within 7 days before randomization must be negative；And agree to use appropriate contraceptive methods throughout the trial period, including at least one barrier method；And no breastfeeding；Male patients must agree to use appropriate contraceptive measures throughout the trial, including at least one barrier method；
Key exclusion criteria (9 listed)
- Alopecia caused by syphilitic alopecia, thyroid disease, trichotilomania, head moss, connective tissue disease, infection, zinc deficiency and iron deficiency;
- Patients with acute diffuse alopecia areata (ADTAFS)
- Patients with active tuberculosis
- The following diseases were combined within 6 months before randomization:thyroid diseases ，liver diseases, malnutrition, heart diseases, nervous system diseases, gastrointestinal disorders, tumors and psychiatric diseases
- HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV-RNA positive at screening；
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 Tablets50 mg twice-daily (BID) | Drug | Jaktinib Hydrochloride Tablets 50mg bid |
| Jaktinib Hydrochloride Tablets150 mg quaque die (QD) | Drug | Jaktinib Hydrochloride Tablets 150mg qd |
| Jaktinib Hydrochloride Tablets200 mg quaque die (QD) | Drug | Jaktinib Hydrochloride Tablets 200mg qd |
Primary outcome
Effective rate
Time frame: From randomization of the first subject until the last subject complete 6 months treatment
Effective rate = (cure + obvious effect + effective)/total cases *100%;
2 secondary outcomes
SALT score change
Time frame: From randomization of the first subject until the last subject complete 6 months treatment
Quality of Life (AASIS)
Time frame: From randomization of the first subject until the last subject complete 6 months treatment
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 29 Nov 2022.
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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.
qianjin Lu, MD principal investigator
Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Alopecia Areata, 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 6 inclusion and 9 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 29 Nov 2022. 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. 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?
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?
Effective rate (time frame: From randomization of the first subject until the last subject complete 6 months treatment). 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 29 Nov 2022.