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CompletedNCT04162899Updated May 9, 2023Results posted

A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

A Phase 2 interventional study of Drug: SHR0302 in Atopic Dermatitis, sponsored by Reistone Biopharma Company Limited. Completed at 23 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Reistone Biopharma Company Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis.

The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 105 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Reistone Biopharma Company Limited is the lead sponsor of 16 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
  • Moderate to severe atopic dermatitis
  • Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion criteria

Exclusion Criteria:

  • Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
  • Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
  • Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    Active Comparator: SHR0302 dose A

    Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.

    Drug: Drug: SHR0302

  • Active comparator
    Active Comparator: SHR0302 dose B

    Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.

    Drug: Drug: SHR0302

  • Active comparator
    Placebo Comparator: Placebo

    Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.

    Drug: Drug: SHR0302

Interventions

  • DrugDrug: SHR0302

    The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).

06

What researchers measure

Primary outcomes

  1. The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.

    The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.

    Time frame: At week 12

Secondary outcomes

  1. Percentage of Czema Area and Severity Index (EASI) Change.

    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

    Time frame: Up to week 12

  2. Percentage of Subjects Achieving Investigator's Global Score (IGA) Response

    The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.

    Time frame: Up to week 8

  3. Percent of Pruritus Numerical Rating Scale (NRS) Change

    The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

    Time frame: Up to week 12

07

Results

Posted May 9, 2023

Participant flow

Participant flow — Overall Study
MilestoneActive Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: Placebo
Started353535
Completed293223
Not completed6312

Outcome measures

PrimaryThe Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.

The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally. IGA response was defined as IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥ 2 from baseline.

Time frame:
At week 12
Reported as:
Count of participants · Participants
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.
ParticipantsActive Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: Placebo
The Percentage of Subjects Achieving Investigator's Global Assessment (IGA) Response Which Improvement ≥ 2 From Baseline.9192
SecondaryPercentage of Czema Area and Severity Index (EASI) Change.

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD).

Time frame:
Up to week 12

Results for this outcome have not been posted.

SecondaryPercentage of Subjects Achieving Investigator's Global Score (IGA) Response

The IGA is a validated assessment instrument used in clinical studies to rate The IGA is a validated assessment instrument used in clinical studies to rate the severity of AD globally.

Time frame:
Up to week 8

Results for this outcome have not been posted.

SecondaryPercent of Pruritus Numerical Rating Scale (NRS) Change

The Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period.

Time frame:
Up to week 12

Results for this outcome have not been posted.

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Active Comparator: SHR0302 Dose A0/35 (0%)2/35 (5.7%)13/35 (37.1%)
Active Comparator: SHR0302 Dose B0/35 (0%)1/35 (2.9%)16/35 (45.7%)
Placebo Comparator: Placebo0/35 (0%)0/35 (0%)10/35 (28.6%)
Most frequent serious events
Most frequent serious events
EventActive Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: Placebo
Dermatitis atopicSkin and subcutaneous tissue disorders2/351/350/35
Most frequent other events
Showing 10 of 14
Most frequent other events
EventActive Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: Placebo
Tri-iodothyronine free increasedInvestigations2/351/354/35
LeukocytosisBlood and lymphatic system disorders3/350/350/35
Transaminases increasedInvestigations2/351/353/35
HyperlipidaemiaMetabolism and nutrition disorders3/352/350/35
HyperuricaemiaMetabolism and nutrition disorders2/353/350/35
Upper respiratory tract infectionInfections and infestations2/351/350/35
FolliculitisInfections and infestations0/352/350/35
Urinary tract infectionInfections and infestations0/352/350/35
Blood creatine phosphokinase increasedInvestigations1/352/350/35
Blood pressure increasedInvestigations0/352/350/35

Baseline characteristics

Age, Continuous
Age, Continuous(years)Active Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: PlaceboTotal
Mean38.5 ± 14.7935.2 ± 14.7530.3 ± 12.5934.7 ± 14.34
Sex: Female, Male
Sex: Female, Male(Participants)Active Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: PlaceboTotal
Female1512936
Male20232669
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Active Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: PlaceboTotal
Hispanic or Latino0000
Not Hispanic or Latino353535105
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Active Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: PlaceboTotal
American Indian or Alaska Native0000
Asian353535105
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White0000
More than one race0000
Unknown or Not Reported0000
Disease duration
Disease duration(years)Active Comparator: SHR0302 Dose AActive Comparator: SHR0302 Dose BPlacebo Comparator: PlaceboTotal
Mean10.91 ± 10.2148.95 ± 8.4688.67 ± 7.6249.51 ± 8.807
08

Study locations

23 sites
  • Peking University People's Hospital
    Xicheng, Beijing, China
  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
    Tianjin, Tianjin 300120, China
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
  • Peking University Third Hospital
    Beijing, 100083, China
  • Peking union medical college hospital
    Beijing, 100730, China
  • Beijing Tsinghua Changgeng Hospital
    Beijing, 102218, China
  • The Second Xiangya Hospital of Central South University
    Changsha, 410008, China
  • Xiangya Hospital of Central South University
    Changsha, 410008, China
  • The Third Xiangya Hospital of Central South University
    Changsha, 410013, China
  • Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
    Chongqing, 400037, China
  • The First Affiliated Hospital of Fujian Medical University
    Fuzhou, 350005, China
  • Guangdong Provincial People's Hospital
    Guangzhou, 510000, China
  • Sun. Yat- Sen Memorial Hospital, Sun. Yat- Sen University
    Guangzhou, 51000, China
  • The first affiliated hospital Zhejiang university
    Hangzhou, 310003, China
  • Affiliated Hangzhou first people's hospital, Zhejiang university school of medicine
    Hangzhou, 310006, China
  • Zhejiang province People's Hospital
    Hangzhou, 310014, China
  • Jinan Central Hospital
    Jinan, 250013, China
  • Shanghai Skin Disease Hospital
    Shanghai, 200050, China
  • The first hospital of China medical university
    Shenyang, 110001, China
  • The First Affiliated Hospital of Soochow University
    Suzhou, 215006, China
  • The First Hospital of Shanxi Medical University
    Taiyuan, 030001, China
  • Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
    Wuhan, 430022, China
  • Henan provincial people's hospital
    Zhengzhou, 450003, China
09

References and documents

Publications

  • Zhao Y, Zhang L, Ding Y, Tao X, Ji C, Dong X, Lu J, Wu L, Wang R, Lu Q, Goh AH, Liu R, Zhang Z, Zhang J. Efficacy and Safety of SHR0302, a Highly Selective Janus Kinase 1 Inhibitor, in Patients with Moderate to Severe Atopic Dermatitis: A Phase II Randomized Clinical Trial. Am J Clin Dermatol. 2021 Nov;22(6):877-889. doi: 10.1007/s40257-021-00627-2. Epub 2021 Aug 9. PubMed 34374027 ↗

Study documents

  • Study protocol · Mar 14, 2019
  • Statistical analysis plan · Sep 24, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04162899
Lead sponsor
Reistone Biopharma Company Limited
Responsible party
Sponsor
First posted
Nov 14, 2019
Start date
Nov 6, 2019
Primary completion
Aug 21, 2020
Completion
Aug 31, 2020
Results posted
May 9, 2023
Last update
May 9, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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