Moderate-to-severe Atopic DermatitisPhase 2NCT06158490
A Study to Evaluate JYP0061 Tablets in Patients With Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing JYP0061 15 mg and JYP0061 30 mg in people with Moderate-to-severe Atopic Dermatitis, run by Guangzhou JOYO Pharma Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are: The efficacy of JYP0061 in treating adult patients with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate-to-severe Atopic Dermatitis
- What is being tested?
- JYP0061 15 mg and JYP0061 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2023to 10 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The age of the participants should be between 18 and 65 years old, with no restrictions on gender.
- Participants must weigh 40 kg or more
- At the time of screening, participants must meet the Williams criteria for atopic dermatitis, have had the condition for at least one year, and the severity of the disease should be moderate to severe;
- Participants agree from the time of signing the informed consent form until the completion of the study's final visit to use only non-medicated emollients (moisturizing creams) or other concomitant treatments allowed by the protocol.
- Fully understand the purpose and requirements of this trial, voluntarily participate, and sign the written informed consent form, and are able to complete the study according to its requirements.
Who cannot join
- Suspected or confirmed allergy to any component of the study drug or similar ingredients, or having a history of moderate allergic diseases (such as food allergies, drug allergies, etc., except for allergies related to atopic dermatitis) at the time of signing the informed consent form;
- At the time of screening, having other skin diseases or skin infections that could affect the evaluation of the trial results, or having extensive tattoos, birthmarks, skin scars, etc., in the area of skin lesions, aside from atopic dermatitis;
- Having or having had other connective tissue diseases, apart from a history of atopic dermatitis;
- Participation in another clinical trial within one month prior to screening or within five half-lives of the investigational drug (whichever is longer);
- Underwent major surgery within 12 weeks prior to screening;
- Conditions that negatively affect the immune response (such as history of organ transplantation), or subjects with known immunodeficiency syndromes (acquired immunodeficiency syndrome, genetic immunodeficiency, and drug-induced immunodeficiency).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Efficacy and Safety Study of JYP0061 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial
The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are:
- The efficacy of JYP0061 in treating adult patients with moderate-to-severe atopic dermatitis.
- The safety profile of JYP0061 when administered to adult patients with moderate-to-severe atopic dermatitis.
Participants will:
- Be treated with either a low-dose or high-dose of JYP0061.
- Undergo efficacy and safety evaluations as stipulated in the trial protocol.
Read the detailed description
The goal of this clinical trial is to assess JYP0061 for efficacy and safety in adult patients with moderate-to-severe atopic dermatitis. The main objectives it aims to address are the determination of the drug's therapeutic effect and its safety profile in this patient population. Upon providing written informed consent after being briefed on the study details and potential risks, participants will enter a screening period of up to 4 weeks to confirm their eligibility.
The main tasks for participants will include:
- Being randomized to receive either a low-dose or high-dose of JYP0061.
- Completing a treatment course of 12 weeks.
- Undergoing efficacy and safety assessments as prescribed by the study's protocol.
Following the treatment phase, all participants, whether they have completed the treatment course on schedule or have discontinued early, will be monitored for an additional 4 weeks to further evaluate safety post-treatment.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- JYP0061 15 mg, JYP0061 30 mg, Placebo
- Keywords
- atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYP0061 15 mgDrug
Participants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks.
JYP0061 30 mgDrug
articipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks.
PlaceboDrug
Participants in the placebo group will receive a matching placebo tablet once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JYP0061 15 mg Group | Experimental | Participants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks. Receives: Drug: JYP0061 15 mg |
| JYP0061 30 mg Group | Experimental | articipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 12 weeks. Receives: Drug: JYP0061 30 mg |
| Placebo Group | Placebo comparator | Participants in this arm will receive a placebo once daily for a total treatment period of 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.
The Eczema Area and Severity Index (EASI) is a measure of eczema severity, combining area coverage and symptom intensity (erythema, edema/papulation, excoriation, lichenification) for four body regions. EASI scores range from 0 (no eczema) to 72 (maximum severity), with higher scores indicating worse outcomes. This primary outcome assesses the proportion of participants who achieve at least a 75% reduction in EASI from baseline to Week 12.
Measured: Evaluations will be conducted weekly for up to 12 weeks
Secondary outcomes (1)
Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.
Percentage of participants achieving a 75% reduction in EASI from baseline at each specified week.
Measured: Weeks 2, 4, and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start27 Dec 2023
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou JOYO Pharma Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158490
- Sponsor's protocol ID
- JYP0061M210
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of JYP0061 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06158490
- Acronym / sponsor ID
- JYP0061M210
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Keywords
- atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou JOYO Pharma Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 6 Dec 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.
The goal of this clinical trial is to evaluate the efficacy and safety of JYP0061 in adult patients with moderate-to-severe atopic dermatitis. The main questions it aims to answer are:
- The efficacy of JYP0061 in treating adult patients with moderate-to-severe atopic dermatitis.
- The safety profile of JYP0061 when administered to adult patients with moderate-to-severe atopic dermatitis.
Participants will:
- Be treated with either a low-dose or high-dose of JYP0061.
- Undergo efficacy and safety evaluations as stipulated in the trial protocol.
Detailed description
The goal of this clinical trial is to assess JYP0061 for efficacy and safety in adult patients with moderate-to-severe atopic dermatitis. The main objectives it aims to address are the determination of the drug's therapeutic effect and its safety profile in this patient population. Upon providing written informed consent after being briefed on the study details and potential risks, participants will enter a screening period of up to 4 weeks to confirm their eligibility.
The main tasks for participants will include:
- Being randomized to receive either a low-dose or high-dose of JYP0061.
- Completing a treatment course of 12 weeks.
- Undergoing efficacy and safety assessments as prescribed by the study's protocol.
Following the treatment phase, all participants, whether they have completed the treatment course on schedule or have discontinued early, will be monitored for an additional 4 weeks to further evaluate safety post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JYP0061 15 mg Group | Experimental | Drug: JYP0061 15 mgParticipants in this arm will receive 15 mg of JYP0061 once daily for a total treatment period of 12 weeks. |
| JYP0061 30 mg Group | Experimental | Drug: JYP0061 30 mgarticipants in this arm will receive 30 mg of JYP0061 once daily for a total treatment period of 12 weeks. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants in this arm will receive a placebo once daily for a total treatment period of 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age of the participants should be between 18 and 65 years old, with no restrictions on gender.
- Participants must weigh 40 kg or more
- At the time of screening, participants must meet the Williams criteria for atopic dermatitis, have had the condition for at least one year, and the severity of the disease should be moderate to severe;
- Participants agree from the time of signing the informed consent form until the completion of the study's final visit to use only non-medicated emollients (moisturizing creams) or other concomitant treatments allowed by the protocol.
- Fully understand the purpose and requirements of this trial, voluntarily participate, and sign the written informed consent form, and are able to complete the study according to its requirements.
Key exclusion criteria (6 listed)
- Suspected or confirmed allergy to any component of the study drug or similar ingredients, or having a history of moderate allergic diseases (such as food allergies, drug allergies, etc., except for allergies related to atopic dermatitis) at the time of signing the informed consent form;
- At the time of screening, having other skin diseases or skin infections that could affect the evaluation of the trial results, or having extensive tattoos, birthmarks, skin scars, etc., in the area of skin lesions, aside from atopic dermatitis;
- Having or having had other connective tissue diseases, apart from a history of atopic dermatitis;
- Participation in another clinical trial within one month prior to screening or within five half-lives of the investigational drug (whichever is longer);
- Underwent major surgery within 12 weeks prior to 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 |
|---|---|---|
| JYP0061 15 mgParticipants in the JYP0061 15 mg group will receive a 15 mg oral tablet of JYP0061 once daily for 12 weeks. | Drug | JYP0061 15 mg Group |
| JYP0061 30 mgarticipants in the JYP0061 30 mg group will receive a 30 mg oral tablet of JYP0061 once daily for 12 weeks. | Drug | JYP0061 30 mg Group |
| PlaceboParticipants in the placebo group will receive a matching placebo tablet once daily for 12 weeks. | Drug | Placebo Group |
Primary outcome
Proportion of participants achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline.
Time frame: Evaluations will be conducted weekly for up to 12 weeks
The Eczema Area and Severity Index (EASI) is a measure of eczema severity, combining area coverage and symptom intensity (erythema, edema/papulation, excoriation, lichenification) for four body regions. EASI scores range from 0 (no eczema) to 72 (maximum severity), with higher scores indicating worse outcomes. This primary outcome assesses the proportion of participants who achieve at least a 75% reduction in EASI from baseline to Week 12.
1 secondary outcome
Proportion of participants achieving EASI 75 at Weeks 2, 4, and 8.
Time frame: Weeks 2, 4, and 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JYP0061 15 mg and JYP0061 30 mg in people with Moderate-to-severe Atopic Dermatitis, run by Guangzhou JOYO Pharma 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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 20 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. 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 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?
This study is still under way. Results are not available in the source record yet.
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 at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from baseline. (time frame: Evaluations will be conducted weekly for up to 12 weeks). 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 20 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.