Alopecia Areata(AA)Phase 1/2AANCT04445363
A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata
A Phase 1/2 study testing Jaktinib hydrochloride cream in people with Alopecia Areata(AA), run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study includes a dose escalation part(phase I) and a dose extension part(phase II). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata(AA)
- What is being tested?
- Jaktinib hydrochloride cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2020to 1 Dec 2024
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ~ 65 years old (including boundary value), regardless of gender;
- Diagnosis of Alopecia Areata;
- Hair loss accounts for 5% ~ 49% of the total scalp area;
- The duration of hair loss is at least 6 months, the longest is not more than 5 years;
- Patients can complete treatment for at least 6 months;
- About Fertility needs meet the following criteria: The results of serum pregnancy tests performed by fertile women during screening visits must be negative, and the results of human chorionic gonadotropin tests performed before the initiation of the study drug must be negative;Women who were fertile and men who had not received vasectomies were required to use effective contraception throughout the study period beginning with the informed consent and up to six months after the last administration;
- Subjects will voluntarily participate in the study after learning about the content and potential adverse drug reactions and must sign an IRC-approved informed consent prior to beginning any examination required by the study;
- Subject is willing and able to comply with scheduled visits, treatment plan, study drug administration, and other study procedures.
Who cannot join
- The following causes of hair loss should be excluded: hair loss caused by androgenic alopecia,syphilis, thyroid diseases, etc.
- Acute Diffuse and Total Alopecia of the Female Scalp;
- Prior history of serious chronic diseases, such as thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor and mental illness, etc;
- Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus infection;
- Participated in a trial for a topical or oral JAK inhibitor;
- Allergic reactions to active ingredients or excipients are known or determined by the investigator;
- Receipt of treatment known to potentially affect the course of AA within last 3 month;
- In the opinion of the investigator , the subject is inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xaingya Hospital，central south university
Changsha, Hunan, 410011
About this study
Official title: A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata
This study includes a dose escalation part(phase I) and a dose extension part(phase II).
Read the detailed description
In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers.
In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.
- Conditions
- Alopecia Areata(AA)
- Being tested
- Jaktinib hydrochloride cream, Placebo
- 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 creamDrug
Also called Jaktinib
Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
PlaceboDrug
Dose extension: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1,0.5% Bid | Experimental | Jaktinib hydrochloride cream 0.5% concentration, twice daily Receives: Drug: Jaktinib hydrochloride cream |
| Cohort 1,1.5% Bid | Experimental | Jaktinib hydrochloride cream 1.5% concentration, twice daily Receives: Drug: Jaktinib hydrochloride cream |
| Cohort 1,2.5% Qd | Experimental | Jaktinib hydrochloride cream 2.5% concentration, once daily Receives: Drug: Jaktinib hydrochloride cream |
| Cohort 1,2.5% Bid | Experimental | Jaktinib hydrochloride cream 2.5% concentration, twice daily Receives: Drug: Jaktinib hydrochloride cream |
| Dose extension: Placebo | Placebo comparator | Placebo, twice daily Receives: Drug: Placebo |
| Dose extension: 1.5% Bid | Experimental | Jaktinib hydrochloride cream 1.5% concentration, twice daily Receives: Drug: Jaktinib hydrochloride cream |
| Dose extension: 2.5% Bid | Experimental | Jaktinib hydrochloride cream 2.5% concentration, twice daily Receives: Drug: Jaktinib hydrochloride cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.
Measured: at week 24
Secondary outcomes (1)
Change in Severity of Alopecia Tool (SALT) Score
Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).
Measured: at baseline, at week 12 and at 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 Jun 2020
- Study start12 Aug 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia Areata(AA)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, once daily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive Jaktinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks. In phase II of this trial, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- qianjin lu, M.D., Study chair, The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445363
- Sponsor's protocol ID
- ZGJAKT001
- Acronym
- AA
- Status last verified
- Mar 2024
- First submitted
- 19 Jun 2020
- Last updated
- 6 Mar 2024
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata
- ClinicalTrials.gov ID
- NCT04445363
- Acronym / sponsor ID
- AA / ZGJAKT001
- Conditions
- Alopecia Areata(AA)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 24 Jun 2020 (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 includes a dose escalation part(phase I) and a dose extension part(phase II).
Detailed description
In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers.
In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, once daily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive Jaktinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks. In phase II of this trial, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1,0.5% Bid | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 0.5% concentration, twice daily |
| Cohort 1,1.5% Bid | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 1.5% concentration, twice daily |
| Cohort 1,2.5% Qd | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 2.5% concentration, once daily |
| Cohort 1,2.5% Bid | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 2.5% concentration, twice daily |
| Dose extension: Placebo | Placebo comparator | Drug: PlaceboPlacebo, twice daily |
| Dose extension: 1.5% Bid | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 1.5% concentration, twice daily |
| Dose extension: 2.5% Bid | Experimental | Drug: Jaktinib hydrochloride creamJaktinib hydrochloride cream 2.5% concentration, twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 ~ 65 years old (including boundary value), regardless of gender;
- Diagnosis of Alopecia Areata;
- Hair loss accounts for 5% ~ 49% of the total scalp area;
- The duration of hair loss is at least 6 months, the longest is not more than 5 years;
- Patients can complete treatment for at least 6 months;
Key exclusion criteria (8 listed)
- The following causes of hair loss should be excluded: hair loss caused by androgenic alopecia,syphilis, thyroid diseases, etc.
- Acute Diffuse and Total Alopecia of the Female Scalp;
- Prior history of serious chronic diseases, such as thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, tumor and mental illness, etc;
- Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus infection;
- Participated in a trial for a topical or oral JAK inhibitor;
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 creamAlso: JaktinibJaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks | Drug | Cohort 1,0.5% Bid, Cohort 1,1.5% Bid, Cohort 1,2.5% Bid, Cohort 1,2.5% Qd, Dose extension: 1.5% Bid, Dose extension: 2.5% Bid |
| PlaceboDose extension: Placebo | Drug | Dose extension: Placebo |
Primary outcome
Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
Time frame: at week 24
SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.
1 secondary outcome
Change in Severity of Alopecia Tool (SALT) Score
Time frame: at baseline, at week 12 and at week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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, M.D. study chair
The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Jaktinib hydrochloride cream in people with Alopecia Areata(AA), 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90) (time frame: at 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 6 Mar 2024.