Atopic DermatitisPhase 3NCT06587685
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
A Phase 3 study testing PG-011Gel in people with Atopic Dermatitis, run by Prime Gene Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- PG-011Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 15 Jan 2026
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years old≤ age ≤ 75 years old (including threshold), male or female.
- Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
- AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
- IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.
- %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20%.
- Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
Who cannot join
- Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).
- Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- Any other concomitant skin disorder(e.g. generalized erythroderma, Netherton syndrome, acne, psoriasis, urticaria, pigmentation or extensive scarring）, in the opinion of investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- Participant with chronic or acute infection needs to be treated with systemic antibiotics, antiviral drugs, antiparasitic drugs, anti-antigenic animal drugs or antifungal drugs within 2 weeks before randomization.
- Participant with active acute/chronic bacterial, fungal or viral skin infections (such as herpes simplex, herpes zoster, chickenpox, etc.) before randomization, including but not limited to clinically significant secondary infections of AD or other infections associated with AD lesions.
- Participant has human immunodeficiency virus (HIV) infection, active hepatitis C virus (HCV) infection (anti-HCV positive), active hepatitis B virus (HBV) infection (HBV-DNA \> 2000IU/ml) or Treponema pallidum antibody positive and showing active.
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- Clinically significant or uncontrolled cardiovascular disease (including but not limited to unstable angina, acute myocardial infarction, heart failure, arrhythmia requiring treatment or uncontrolled hypertension).
- Participant has serious diseases or complications of the central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or immune system, blood system, etc., and in the opinion of the investigator, may affect the judgment of efficacy and safety .
- Participant has mental illness such as anxiety disorder, depression, or other conditions that affect the compliance and may interfere with the implementation of clinical research.
- Participant has a history of malignant tumors before randomization.
- Participant has severe and uncontrolled disease that may affect safety, trial compliance, affect the evaluation of endpoints, and require the use of drugs that are not allowed in the protocol.
- Female participant who is lactating or pregnant at the time of screening.
- Any situation affects the safety and efficacy evaluation of the study drug judged by investigator.
- Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li Zhang, Professor contact
China1 site, 1 recruiting
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Xin Hua GAO, +86 13940152467, barrygao@hotmail.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis
This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis.
Read more
Participants will:
- Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week.
- Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week.
- Keep a diary of their symptoms.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old (including threshold) with mild to moderate Atopic Dermatitis. Approximately 472 participants will be randomized 3:1 to PG-011 gel 3% BID, or placebo gel. In addition, approximately 10% of the overall study population will consist of adolescents. Participants with AD involvement of 3% to 20% BSA and IGA score of 2 to 3 will receive blinded study treatment for 8 weeks followed by an open-label treatment for 44 weeks, at last the safety follow-up for 2 weeks.
The study is to evaluate the efficacy and long-term safety of PG-011 gel 3% in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling.
- Conditions
- Atopic Dermatitis
- Being tested
- PG-011Gel, Vehicle
- Keywords
- Atopic Dermatitis, PG-011, Pumecitinib, Atopic, Dermatitis
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-011GelDrug
Also called PG-011Gel 3%
Twice daily for 52 weeks or 44 weeks
VehicleDrug
Also called placebo
Vehicle Gel twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PG-011Gel 3% | Experimental | Topically administered Pumecitinib Gel 3% to the skin twice daily for 52 or 44 weeks Receives: Drug: PG-011Gel |
| Vehicle Gel | Placebo comparator | Topically administered the Vehicle Gel to the skin twice daily for 8 weeks Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8
Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: 8-week
Secondary outcomes (28)
Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0/1 at Week 8
Proportion of participants achieving Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline at Week 8.
Measured: 8-week
Proportion change of eczema area and severity index (EASI) at each scheduled visit
Proportion change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change of eczema area and severity index (EASI) score at each scheduled visit
Value change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit
The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The NRS score ranges from 0 to 10 points, higher score indicates greater intensity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit
Child Dermatology Life Quality Index (CDLQI) are designed to measure the impact of any skin disease on the lives of children. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit
Child Dermatology Life Quality Index (CDLQI) are designed to measure the impact of any skin disease on the lives of children. The CDLQI score ranges from 0 to 30 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of the Patient-oriented eczama Measure (POEM) score at each scheduled visit.
The Patient-oriented eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of affected body surface area (BSA) at each scheduled visit
Total body surface area(BSA) is 100%, and the proportion of affected body surface area(BSA) is ranged from 0 to100%, higher value indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of the Patient-oriented Eczama Measure (POEM) score at each scheduled visit.
The Patient-oriented Eczama Measure (POEM) is a comprehensive assessment of the patient own assessment of clinical symptoms in the past week. The POEM score ranges from 0 to 28 points, higher score indicate greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.
Scoring Atopic Dermatitis(SCORAD) is a tool to assess the extent and severity of eczema and will be completed before, during, and after treatment has begun to determine whether the treatment has been effective. The SCORAD score ranges from 0 to 103, and higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.
Scoring Atopic Dermatitis(SCORAD) is a tool to assess the extent and severity of eczema and will be completed before, during, and after treatment has begun to determine whether the treatment has been effective. The SCORAD score ranges from 0 to 103, and higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.
Dermatology Life Quality Index (DLQI) is designed to measure the impact of any skin disease on the lives of adults.The DLQI score ranges from 0 to 30 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.
Dermatology Life Quality Index (DLQI) is designed to measure the impact of any skin disease on the lives of adults.The DLQI score ranges from 0 to 30 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of the sites achieving Investigators Global Assessment(IGA) 0/1 from baseline
Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of the sites achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline
Average time to achieve Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline by using PG-011gel or a placebo. The IGA score ranges from 0 to 4 points, higher score indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 at each scheduled visit
The IGA score ranges from 0 to 4 points, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at each scheduled visit
The IGA score ranges from 0 to 4 points, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The average time of achieving Investigators Global Assessment (IGA) 0/1 at the atopic dermatitis (AD) target site
The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at the atopic dermatitis (AD) target site
The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving at least a 3-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit
The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The Itch Numeric Rating Scale(NRS) score ranges from 0 to 10 points, higher score indicates greater intensity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of participants achieving at least a 4-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit
The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The Itch Numeric Rating Scale(NRS) score ranges from 0 to 10 points, higher score indicates greater intensity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change from baseline of affected Body Surface Area (BSA) at each scheduled visit
Total Body Surface Area(BSA) is 100%, and the proportion of affected BSA is ranged from 0 to100%, higher value indicates greater severity.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 in Atopic Dermatitis (AD) target site at each scheduled visit
The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear.
Measured: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline in Atopic Dermatitis (AD) target site at each scheduled visit
The target site is a representative site of atopic dermatitis skin lesions selected by the investigator. The Investigators Global Assessment (IGA) score ranges from 0 to 4 points, higher score indicates greater severity. The IGA score 0 means clear and IGA score 1 means almost clear.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 50 at each scheduled visit
Defined as at least 50% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 75 at each scheduled visit
Defined as at least 75% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 90 at each scheduled visit
Defined as at least 90% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 100 at each scheduled visit
Defined as at least 100% improvement from baseline in Eczema Area and Severity Index(EASI) score at each scheduled visit.The EASI score ranges from 0 to 72, higher score indicates greater severity.
Measured: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Mar 2024
- Primary completion19 Nov 2024
- Study completion15 Jan 2026 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinghua Gao, Study chair, First Hospital of China Medical UniversityZhiQiang Xie, Professor, Principal investigator, Beijing HospitalLitao Zhang, Principal investigator, Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalYunsheng Liang, Principal investigator, Dermatology Hospital of Southern Medical UniversityWenli Feng, Principal investigator, Second Hospital of Shanxi Medical UniversityChao Ji, Principal investigator, First Affiliated Hospital of Fujian Medical UniversityAie Xu, Principal investigator, Hangzhou Third People's HospitalBingjiang Lin, Principal investigator, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587685
- Sponsor's protocol ID
- PG-011-AD-301
- Other IDs
- CTR20230499
- Status last verified
- May 2025
- First submitted
- 14 Aug 2024
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06587685
- Acronym / sponsor ID
- PG-011-AD-301
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, PG-011, Pumecitinib, Atopic, Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Prime Gene Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 19 Sep 2024 (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 is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis.
Participants will:
- Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week.
- Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week.
- Keep a diary of their symptoms.
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in adolescent and adult participants aged from 12 to 75 years old (including threshold) with mild to moderate Atopic Dermatitis. Approximately 472 participants will be randomized 3:1 to PG-011 gel 3% BID, or placebo gel. In addition, approximately 10% of the overall study population will consist of adolescents. Participants with AD involvement of 3% to 20% BSA and IGA score of 2 to 3 will receive blinded study treatment for 8 weeks followed by an open-label treatment for 44 weeks, at last the safety follow-up for 2 weeks.
The study is to evaluate the efficacy and long-term safety of PG-011 gel 3% in the treatment of mild to moderate Atopic Dermatitis and the PK characteristics by sparse sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG-011Gel 3% | Experimental | Drug: PG-011GelTopically administered Pumecitinib Gel 3% to the skin twice daily for 52 or 44 weeks |
| Vehicle Gel | Placebo comparator | Drug: VehicleTopically administered the Vehicle Gel to the skin twice daily for 8 weeks |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 years old≤ age ≤ 75 years old (including threshold), male or female.
- Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
- AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
- IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.
- %BSA (excluding the scalp) with AD involvement of at least 10% and up to 20%.
Key exclusion criteria (14 listed)
- Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).
- Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
- Any other concomitant skin disorder(e.g. generalized erythroderma, Netherton syndrome, acne, psoriasis, urticaria, pigmentation or extensive scarring）, in the opinion of investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- Participant with chronic or acute infection needs to be treated with systemic antibiotics, antiviral drugs, antiparasitic drugs, anti-antigenic animal drugs or antifungal drugs within 2 weeks before randomization.
- Participant with active acute/chronic bacterial, fungal or viral skin infections (such as herpes simplex, herpes zoster, chickenpox, etc.) before randomization, including but not limited to clinically significant secondary infections of AD or other infections associated with AD lesions.
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 |
|---|---|---|
| PG-011GelAlso: PG-011Gel 3%Twice daily for 52 weeks or 44 weeks | Drug | PG-011Gel 3% |
| VehicleAlso: placeboVehicle Gel twice daily for 8 weeks | Drug | Vehicle Gel |
Primary outcome
Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8
Time frame: 8-week
Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity.
28 secondary outcomes
Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0/1 at Week 8
Time frame: 8-week
Proportion change of eczema area and severity index (EASI) at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change of eczema area and severity index (EASI) score at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of Child Dermatology Life Quality Index (CDLQI) score at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of the Patient-oriented eczama Measure (POEM) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of affected body surface area (BSA) at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of the Patient-oriented Eczama Measure (POEM) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline in Scoring Atopic Dermatitis (SCORAD) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion change from baseline of Dermatology Life Quality Index (DLQI) score at each scheduled visit.
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of the sites achieving Investigators Global Assessment(IGA) 0/1 from baseline
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of the sites achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
The average time of achieving Investigators Global Assessment (IGA) 0/1 at the atopic dermatitis (AD) target site
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
The average time of achieving Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline at the atopic dermatitis (AD) target site
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving at least a 3-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of participants achieving at least a 4-point decrease of Itch Numeric Rating Scale (NRS) from baseline at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Change from baseline of affected Body Surface Area (BSA) at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of achieving Investigators Global Assessment (IGA) 0/1 in Atopic Dermatitis (AD) target site at each scheduled visit
Time frame: Week1,2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Proportion of Investigators Global Assessment (IGA) 0/1 with at least a 2-point decrease from baseline in Atopic Dermatitis (AD) target site at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 50 at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 75 at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 90 at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of participants achieving Eczema Area and Severity Index(EASI) 100 at each scheduled visit
Time frame: Week 1, 2,4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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 May 2025.
- IGA, Investigator's Global AssessmentLink provided by the sponsor.
- 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.
Li Zhang, Professor contact
Xinghua Gao study chair
First Hospital of China Medical University
ZhiQiang Xie, Professor principal investigator
Beijing Hospital
Litao Zhang principal investigator
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PG-011Gel in people with Atopic Dermatitis, run by Prime Gene Therapeutics 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 May 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 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?
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?
Contact Xinghua Gao, Professor (+86-13940152467, barrygao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8 (time frame: 8-week). 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 May 2025.