Atopic Dermatitis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.
Interventions
DRUGSKB575 Injection/SKB575 Placebo
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Sponsors
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Phase Ia healthy participants must meet all of the following inclusion criteria to be enrolled: 1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form. 2. Age at the time of signing the informed consent form is 18-55 years (inclusive), any gender. 3. Male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg; body mass index \[BMI\] is 18.0-28.0 kg/m² (inclusive). 4. No clinically significant abnormalities. Phase Ib participants with moderate to severe AD must meet all of the following inclusion criteria to be enrolled: 1. The participant is able to understand and comply with the requirements of the study and voluntarily signs the informed consent form. 2. Age at the time of signing the informed consent form is 18-70 years (inclusive), any gender. 3. Participant weight must be ≥ 45.0 kg. 4. At screening, the diagnosis of AD meets the American Dermatology Consensus Criteria (2014) (see Appendix 4) and disease duration is ≥ 1 year; and at both screening and randomization, all of the following conditions are satisfied: 1. EASI ≥ 16 at screening and baseline visits; 2. IGA ≥ 3 (on a 0 4 IGA scale, where 3 = moderate, 4 = severe) at screening and baseline visits; 3. Body surface area (BSA) of lesions ≥ 10% at screening and baseline visits. 5. Prior to screening, the participant has received at least 4 weeks of potent or 2 weeks of super potent topical corticosteroids (or systemic corticosteroids), or topical calcineurin inhibitor.
Exclusion criteria
1. History of any clinically significant disease of the cardiovascular, hematological, hepatic, renal, digestive, neurological, respiratory, or psychiatric systems, or metabolic disorders, or any other disease or physiological condition that may interfere with the trial results. 2. History of malignancy, regardless of whether treated, and regardless of the presence or absence of signs of local recurrence or metastasis. 3. Presence of skin scars, induration, inflammation, edema, ulceration, infection, bleeding, or other conditions at the intended injection site that are unsuitable for subcutaneous injection. 4. Clinical signs of active infection within 4 weeks prior to randomization, including but not limited to urogenital infection, pulmonary infection, acute sinusitis, appendicitis, bloodstream infection, etc. 5. History of tuberculosis or complications of tuberculosis, or positive/abnormal findings of clinical significance based on chest X-ray/chest CT, physical examination, and T-cell interferon-gamma release assay (TIGRA) (e.g., T-Spot or Quanti-FERON®-TB Gold™). 6. Subjects positive for Hepatitis B (HBsAg, HBeAg, HBeAb, or HBcAb), positive for Hepatitis C antibody, positive for HIV antibody, or positive for syphilis serology. NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) /TEAEs | From Baseline to Day 225 | Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs) |
| Proportion of participants achieving EASI-75 at Week 16 | From Baseline throughout the study, up to Week 16 | EASI 75 is defined by reduction of EASI score by ≥75% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) assessment: Cmax | From baseline to Day 225 | Maximum plasma concentration |
| Pharmacokinetic (PK) assessment: Tmax | From baseline to Day 225 | Time to reach Cmax |
| Pharmacokinetic (PK) assessment: AUClast | From baseline to Day 225 | Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration |
| Presence of Anti-SKB575 Antibodies (ADA) | From baseline to Day 225 | Positive rate of participant with SKB575 antibodies |
| Pharmacodynamic (PD) Characteristics: Eosinophil | From baseline to Day 225 | Change from baseline in total serum target concentrations of eosinophil |
| Pharmacodynamic (PD) Characteristics: IgE | From baseline to Day 225 | Change from baseline in total serum target concentrations of IgE |
| Pharmacodynamic (PD) Characteristics: TARC | From baseline to Day 225 | Change from baseline in total serum target concentrations of TARC |
Countries
China
Contacts
CONTACTXin Li, PhD
Outcome results
None listed