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Dermatitis, AtopicPhase 2NCT05544591

Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing 611 Q2W and 611 Q4W in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatitis, Atopic
What is being tested?
611 Q2W and 611 Q4W
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
5 sitesChina
Study dates
26 Oct 2022to 20 Sep 2023
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
  • Male or female adults ages 18 to 64 years old when signing the informed consent.
  • AD (according to American Academy of Dermatology Consensus Criteria, 2014) that had been present for at least 1 years before the screening visit.
  • Eczema Area and Severity Index (EASI) score greater than or equal to (>=) 16 at the screening and baseline visits.
  • Investigator's Global Assessment (IGA) score >=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
  • Participants with >=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
Show all 10Show fewer
  • Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity >=4.
  • Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
  • Have applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit.
  • Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

Who cannot join

  • Presence of skin comorbidities that may interfere with study assessments
  • Presence of active endoparasitic infections; or suspected endoparasitic.
  • Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
  • History of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
  • Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
Show all 18Show fewer
  • Active TB, unless that was well documented that the participants had adequately treated.
  • Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study
  • Patients who have received any of the following treatments: a) Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, PDE inhibitors, or Janus kinase (JAK) inhibitors within 2 weeks before baseline; b) Treatment with systemic traditional Chinese medicine (TCM) within 4 weeks before baseline or treatment with topical TCM; c) Have undergone bleaching baths ≥ twice within 2 weeks before baseline; d) Treatment with systemic corticosteroids or other immunosuppressive/immunomodulating substances (e.g., cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, interferon-gamma [IFN-γ], oral JAK inhibitors, compound glycyrrhizin, azathioprine, mycophenolate mofetil, or methotrexate,) within 4 weeks before baseline or 5 drug half-lives (if known), whichever is longer; e) Treatment with phototherapy (narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light emitting device (LED) therapy within 4 weeks before baseline; f) Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline. Treatment with other biological agents (e.g., dupilumab) within 3 months before baseline or 5 drug half-lives (if known), whichever is longer; g) History of inadequate response to treatment with anti-IL-4 and/or IL13 agents (e.g., dupilumab), in the opinion of the investigator. h) Treatment with allergen specific immunotherapy (SIT) within 6 months before the screening visit. i) Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (participants may continue using stable doses of such moisturizers if initiated before the screening visit).
  • Presence of any one of the following lab abnormalities at screening or baseline: a) Total bilirubin > 1.5 times the upper limit of normal (ULN); b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 ULN; c) Serum creatinine (Cr) > 1.5×ULN; d) White blood cell count below the lower limit of normal (LLN) , was judged clinically significant by the investigator, and not suitable for inclusion in the study;
  • HBsAg-positive with HBV DNA copy number beyond normal limit of the HBV DNA test, or HCV antibodies (HCV Ab)-positive with HCV RNA copy number beyond normal limit of the HCV RNA test, human immunodeficiency virus antibody (HIV Ab) positive, serum syphilis helix antibody (TP Ab) positive with syphilis helix titrating positive at screening;
  • History of alcohol or drug abuse within 6 months before baseline.
  • History of hypersensitivity to 611 or their excipients.
  • Have been vaccinated with live (attenuated) vaccine within 2 months before baseline or planned during the study period;
  • Have used any investigational drug/treatment within 8 weeks before baseline;
  • Planned or anticipated major surgical procedure during the patient's participation in this study.
  • Pregnant or lactating women, or subjects with pregnancy or lactation plans during the study period.
  • Any reason which, in the opinion of investigator, would prevent the subject from participating in the study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine

    Jinhua, Zhejiang, 322000

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330200

Other trials in China

About this study

Official title: A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase II Clinical Trial, to Evaluate the Efficacy and Safety of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis.

The primary objective of the study was to evaluate the efficacy and safety of 611 in chinese adults with moderate to severe atopic dermatitis.

Read the detailed description

The maximum study duration was 28 weeks per participants, including a screening period of up to 4 weeks, a 16-week randomized treatment period, and a 8-week follow-up period.

Being tested
611 Q2W, 611 Q4W, Matching placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 611 Q2WDrug

    subcutaneous injection, 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 2 to Week 14, 7 cycles)

  • 611 Q4WDrug

    subcutaneous injection, 600mg (loading dose, Day1) + 300mg Q4W (maintenance dose, on week 4, 8, 12) + placebo Q4W (on week 2, 6, 10, 14)

  • Matching placeboDrug

    Also called placebo

    subcutaneous injection, Q2W, from Week 2 to Week 14, 7 cycles

Study groups in NCT05544591
Study groupRoleWhat they receive
611 Q2WExperimentalFour subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q2w from Week 2 to Week 14 (7 cycles).
Receives: Drug: 611 Q2W
611 Q4WExperimentalFour subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on week 0 Day 1, followed by two 150 mg injections (for a total of 300 mg) q4w on week 4, 8, 12 and two injections of placebo on week 2, 6, 10, 14.
Receives: Drug: 611 Q4W
placeboPlacebo comparatorFour subcutaneous injections of placebo as a loading dose on week 0 Day 1, followed by two injections q2w from Week 2 to Week 14 (7 cycles).
Receives: Drug: Matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline, Week 16

Secondary outcomes (25)

  1. Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline, Week 16

  2. Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline, Week 16

  3. Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16

    The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 16

  4. Number of Participants Who Achieve Improvement of IGA Score by >=2 From Baseline to Week 16

    The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

    Measured: Baseline to Week 16

  5. Number of Participants Who Achieved >=4 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline to Week 16

  6. Number of Participants Who Achieved >=3 Points With Improvement From Baseline in Weekly Average of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline to Week 16

  7. Percentage Change From Baseline to Week 16 in EASI Score

    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

    Measured: Baseline to Week 16

  8. Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement

    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.

    Measured: Baseline to Week 16

  9. Change From Baseline at Week 16 in Weekly Average of Pruritus NRS

    Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

    Measured: Baseline to Week 16

  10. Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score

    The DLQI was a validated questionnaire used to measure the impact of AD disease symptoms and treatment on health-related quality of life (QOL). DLQI consisting of a set of 10 questions which assess QOL over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.

    Measured: Baseline to Week 16

  11. Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.

    Measured: Baseline to Week 16

  12. Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.

    The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

    Measured: Up to 24 Weeks

  13. Maximum Concentration (Cmax).

    Maximum Observed Serum Concentration (Cmax) of 611

    Measured: Baseline to Week 24.

  14. Minimum concentration (Cmin).

    Minimum concentration (Cmin) of 611.

    Measured: Baseline to Week 24.

  15. Time to Reach the Maximum Concentration (Tmax).

    Time to Reach the Maximum Serum Concentration (Tmax) of 611.

    Measured: Baseline to Week 24.

  16. Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last).

    Area under the serum concentration-time curve from 0 to the time of the last quantifiable concentration (AUC0-last) of 611.

    Measured: Baseline to Week 24.

  17. AUC to the end of the dosing period (AUC0-tau)

    AUC to the end of the dosing period (AUC0-tau) of 611.

    Measured: Baseline to Week 24.

  18. Clearance rate (CL/F).

    Clearance rate (CL/F) of 611.

    Measured: Baseline to Week 24.

  19. Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.

    Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants * 100%.

    Measured: Baseline to Week 24.

  20. Change in serum concentrations of Thymus and activation regulated chemokine (TARC)

    Change in serum concentrations of TARC

    Measured: Baseline to Week 24.

  21. Change in serum concentrations of IL-4

    Change in serum concentrations of IL-4

    Measured: Baseline to Week 24.

  22. Change in serum concentrations of IL-13

    Change in serum concentrations of IL-13.

    Measured: Baseline to Week 24.

  23. Change in serum concentrations of IgE

    Change in serum concentrations of IgE.

    Measured: Baseline to Week 24.

  24. Change in whole blood eosinophil counts

    Change in whole blood eosinophil counts.

    Measured: Baseline to Week 24.

  25. Change in serum concentrations of lactate dehydrogenase (LDH)

    Change in serum concentrations of lactate dehydrogenase (LDH).

    Measured: Baseline to Week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start26 Oct 2022
  3. Primary completion10 Jul 2023
  4. Study completion20 Sep 2023

Resources

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544591
Sponsor's protocol ID
SSGJ-611-AD-II-01
Status last verified
Nov 2022
First submitted
9 Sep 2022
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, Zhang L, Wu L, Duan X, Ji C, Xiao R, Ji M, Liu L, Yang B, Hu G, Feng Y, Zhu J, Li J, Ding Y, Huang H, Zhou Q, Xu Y, Zhang J. Efficacy and Safety of 611 in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: Results from a Phase II Trial. Dermatol Ther (Heidelb). 2025 Apr;15(4):857-867. doi: 10.1007/s13555-025-01368-4. Epub 2025 Mar 9.

    PubMed 40057938

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 611 Q2W and 611 Q4W in people with Dermatitis, Atopic, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 5 sites 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 10 inclusion and 18 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

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?

Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05544591, which also lists 1 linked publication.

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 1 Feb 2024.

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