Atopic DermatitisPhase 1/2NCT04435392
Jaktinib Hydrochloride Cream For Atopic Dermatitis
A Phase 1/2 study testing Jaktinib Hydrochloride Cream in people with Atopic Dermatitis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This study includes a dose escalation part and a dose extension part. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Jaktinib Hydrochloride Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2020to 8 Sep 2022
- 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), gender is not limited;
- Have a clinical diagnosis of atopic dermatitis;
- Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;
- The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline.
Who cannot join
- Evidence of certain skin conditions/infections at baseline;
- Have certain laboratory abnormalities at baseline;
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;
- Other conditions that the investigators considered inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008
About this study
Official title: A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis
This study includes a dose escalation part and a dose extension part.
Read the detailed description
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.
The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.
- Conditions
- Atopic Dermatitis
- Being tested
- Jaktinib Hydrochloride Cream, Placebo
- Keywords
- Atopic Dermatitis, Jaktinib
- 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 CreamDrug
Also called Jaktinib
Subjects in each group were scheduled to give the drug for 8 weeks.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1, 0.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily. Receives: Drug: Jaktinib Hydrochloride Cream; Drug: Placebo |
| Part 1: Cohort 2,1.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily. Receives: Drug: Jaktinib Hydrochloride Cream; Drug: Placebo |
| Part 1: Cohort 3, 2.5% Jaktinib Qd | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily. Receives: Drug: Jaktinib Hydrochloride Cream; Drug: Placebo |
| Part 1: Cohort 4, 2.5% Jaktinib Bid | Experimental | Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily. Receives: Drug: Jaktinib Hydrochloride Cream; Drug: Placebo |
| Dose extension: Vehicle Control | Placebo comparator | the Vehicle Control cream will be applied topically twice daily Receives: Drug: Placebo |
| Dose extension: low-dose group, X% | Experimental | X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily Receives: Drug: Jaktinib Hydrochloride Cream |
| Dose extension: high-dose group, Y% | Experimental | Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily Receives: Drug: Jaktinib Hydrochloride Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
A total PGA score of 0 or 1 or a decrease of ≥2 from baseline
Measured: 7 days after the last dose
Secondary outcomes (1)
Proportion of Participants With Response of Clear or Almost Clear From Baseline
PGA score of 0 or 1
Measured: Treatment at 8,16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start14 Oct 2020
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qianjin Lu, PhD, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435392
- Sponsor's protocol ID
- ZGJAKT002
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2020
- Last updated
- 2 Apr 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 2 Apr 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 PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04435392
- Acronym / sponsor ID
- ZGJAKT002
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Jaktinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 17 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 and a dose extension part.
Detailed description
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.
The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) : Extension test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1, 0.5% Jaktinib Bid | Experimental | Drug: Jaktinib Hydrochloride Cream, Drug: PlaceboSubjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily. |
| Part 1: Cohort 2,1.5% Jaktinib Bid | Experimental | Drug: Jaktinib Hydrochloride Cream, Drug: PlaceboSubjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily. |
| Part 1: Cohort 3, 2.5% Jaktinib Qd | Experimental | Drug: Jaktinib Hydrochloride Cream, Drug: PlaceboSubjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily. |
| Part 1: Cohort 4, 2.5% Jaktinib Bid | Experimental | Drug: Jaktinib Hydrochloride Cream, Drug: PlaceboSubjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily. |
| Dose extension: Vehicle Control | Placebo comparator | Drug: Placebothe Vehicle Control cream will be applied topically twice daily |
| Dose extension: low-dose group, X% | Experimental | Drug: Jaktinib Hydrochloride CreamX% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily |
| Dose extension: high-dose group, Y% | Experimental | Drug: Jaktinib Hydrochloride CreamY% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18~ 65 years old (including boundary value), gender is not limited;
- Have a clinical diagnosis of atopic dermatitis;
- Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;
- The total area of atopic dermatitis is about 10%~20% of the total area of the body surface at baseline.
Key exclusion criteria (4 listed)
- Evidence of certain skin conditions/infections at baseline;
- Have certain laboratory abnormalities at baseline;
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;
- Other conditions that the investigators considered inappropriate to participate in 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 CreamAlso: JaktinibSubjects in each group were scheduled to give the drug for 8 weeks. | Drug | Dose extension: high-dose group, Y%, Dose extension: low-dose group, X%, Part 1: Cohort 1, 0.5% Jaktinib Bid, Part 1: Cohort 2,1.5% Jaktinib Bid, Part 1: Cohort 3, 2.5% Jaktinib Qd, Part 1: Cohort 4, 2.5% Jaktinib Bid |
| PlaceboPlacebo | Drug | Dose extension: Vehicle Control, Part 1: Cohort 1, 0.5% Jaktinib Bid, Part 1: Cohort 2,1.5% Jaktinib Bid, Part 1: Cohort 3, 2.5% Jaktinib Qd, Part 1: Cohort 4, 2.5% Jaktinib Bid |
Primary outcome
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
Time frame: 7 days after the last dose
A total PGA score of 0 or 1 or a decrease of ≥2 from baseline
1 secondary outcome
Proportion of Participants With Response of Clear or Almost Clear From Baseline
Time frame: Treatment at 8,16 weeks
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 2 Apr 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, PhD principal investigator
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 Atopic Dermatitis, 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 4 inclusion and 4 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 2 Apr 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?
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?
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear (time frame: 7 days after the last dose). 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 2 Apr 2024.