Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis

NCT05641558 | Completed Phase 1

• 1 other identifier: SSGJ-611-AD-I-C
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 Weeks (Day 197).

Secondary Outcomes (16)

• Maximum Concentration (Cmax).

  Baseline to Week 24 (Day 197).

• Minimum concentration (Cmin).

  Baseline to Week 24 (Day 197).

• Time to Reach the Maximum Concentration (Tmax).

  Baseline to Week 24 (Day 197).

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

  Baseline to Week 24 (Day 197).

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

  Baseline to Week 24 (Day 197).

Study Arms (3)

611 dose 1 plus placebo

EXPERIMENTAL

One subcutaneous injections of 611 150 mg on Day 1, followed by a 4-week observation period. Two subcutaneous injections of 611 150 mg (for a total of 300 mg) as a loading dose on Week 0 Day 29, followed by one 150 mg injection quaque week (QW) from Week 1 to Week 15 (15 cycles).

Drug: 611 150mg; Other: Placebo

611 dose 2 plus placebo

EXPERIMENTAL

Two subcutaneous injections of 611 150 mg (for a total of 300 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection quaque 2 week (Q2W) from Week 1 to Week 15 (8 cycles).

Drug: 611 300mg; Other: Placebo

611 dose 3 plus placebo

EXPERIMENTAL

Four subcutaneous injections of 611 150 mg (for a total of 600 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection QW from Week 1 to Week 15 (15 cycles).

Drug: 611 600mg; Other: Placebo

Interventions

611 150mg DRUG

subcutaneous injection, 150 mg (single dose treatment period) + 300mg (loading dose, week 0) + 150mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)

611 dose 1 plus placebo

611 300mg DRUG

subcutaneous injection, 300 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 1 to Week 15, 8 cycles)

611 dose 2 plus placebo

611 600mg DRUG

subcutaneous injection, 600 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles)

611 dose 3 plus placebo

Placebo OTHER

During the study, placebos shall be filled timely according to the administration of the test drug to ensure the consistency of the times of administration in each group, so as to maintain the blind state.

611 dose 1 plus placebo; 611 dose 2 plus placebo; 611 dose 3 plus placebo

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 years or older who has AD (according to Williams Criteria) at the screening visit.
• AD that had been present for at least 1 year before the baseline visit.
• Body mass index (BMI) was 19-32 kg/m\^2 (including boundary values), male subjects weighed ≥50.0kg, female subjects weighed ≥45.0kg.
• Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16.
• Investigator's Global Assessment (IGA) score \>=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe).
• Participants with \>=10 percent (%) body surface area (BSA) of AD involvement.
• Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity \>=4.
• Recent history (within 6 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 before the baseline visit.
• Subject must be able to understand and complete the study related questionnaires and sign the written informed consent (ICF).

You may not qualify if:

• Presence of any one of the following lab abnormalities at screening: Hemoglobin ≤ the lower limit of normal (LLN); White blood cell count below LLN; Neutrophil count below LLN; Blood platelet count below LLN; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN); Total bilirubin ≥ 1.5 × ULN; Serum creatinine (Cr) ≥ 1.5×ULN;
• History of treatment with dupilumab, anti-interleukin (IL)-4 or IL13 agents.
• Patients who have received any of the following treatments within 4 weeks before baseline: Treatment with immunosuppressive/immunomodulating substances (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma \[IFN-γ\], oral JAK inhibitors, compound glycyrrhizin, azathioprine, or methotrexate); 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;
• Treatment with topical drugs such as corticosteroids, topical calcineurin inhibitors, phosphodiesterase (PDE) inhibitors, or Janus kinase (JAK) inhibitors within 1 weeks before baseline;
• Treatment with systemic traditional Chinese medicine (TCM) within 4 weeks before baseline or treatment with topical TCM within 1 weeks before baseline;
• Patients who have received any of the following biological agents: Treatment with cell depletion agents (e.g., rituximab) within 6 months before baseline. Treatment with other biological agents within 3 months before baseline or 5 drug half-lives (if known), whichever is longer;
• Have undergone bleaching baths ≥ twice within 2 weeks before baseline;
• Planned or anticipated use of any banned drugs or any prohibited therapeutic procedures during the study.
• Have been vaccinated with live (attenuated) vaccine within 8 weeks before baseline or planned during the study period or within 12 months after the study;
• History of hypersensitivity to any biological agents. History of hypersensitivity to 611 or their excipients.
• Participants who had donated blood (≥200 ml) within 8 weeks before enrollment or had severe blood loss of ≥200 ml, received a blood transfusion within 8 weeks, or planned to donate blood during the course of the study.
• 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., tuberculosis \[TB\], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis).
• Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
• History of alcohol within 6 months before baseline.

Sponsors & Collaborators

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

Study Sites (5)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

Location

Nanyang First People's Hospital

Nanyang, Henan, 473010, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330001, China

Location

The First of Hospital China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

entacapone

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 Officials

• Xinghua Gao, MD

  The First of Hospital China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: November 2, 2022
• First Posted: December 7, 2022
• Study Start: October 18, 2021
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)