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

NCT05544591 | Completed Phase 2

• 1 other identifier: SSGJ-611-AD-II-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 16

Secondary Outcomes (25)

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

  Baseline, Week 16

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

  Baseline, Week 16

• 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

  Baseline to Week 16

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

  Baseline to Week 16

• 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

  Baseline to Week 16

Study Arms (3)

611 Q2W

EXPERIMENTAL

Four 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).

Drug: 611 Q2W

611 Q4W

EXPERIMENTAL

Four 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.

Drug: 611 Q4W

placebo

PLACEBO COMPARATOR

Four 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).

Drug: Matching placebo

Interventions

611 Q2W DRUG

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

611 Q2W

611 Q4W DRUG

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

611 Q4W

Matching placebo DRUG

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

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).
• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (5)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330200, China

Location

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

Hangzhou, Zhejiang, 310003, China

Location

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Jinhua, Zhejiang, 322000, China

Location

Related Publications (1)

• 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.

  PMID: 40057938 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 16, 2022
• Study Start: October 26, 2022
• Primary Completion: July 10, 2023
• Study Completion: September 20, 2023
• Last Updated: February 1, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)