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

Sunshine Guojian Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: 611 Q2W; Drug: Matching placebo; Drug: 611 Q4W

Study type: Interventional

Funder types: Industry

Identifiers

NCT05544591

SSGJ-611-AD-II-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

93 participants in 3 patient groups, including a placebo group

611 Q2W

Experimental group

Description:

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).

Treatment:

Drug: 611 Q2W

611 Q4W

Experimental group

Description:

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.

Treatment:

Drug: 611 Q4W

placebo

Placebo Comparator group

Description:

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).

Treatment:

Drug: Matching placebo