Psoriasis
Conditions
Brief summary
This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with moderate-to-severe plaque psoriasis
Detailed description
This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of AK111 in subjects with moderate-to-severe plaque psoriasis..
Interventions
DRUGAK111
Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.
DRUGPlacebo
Subjects will receive corresponding dose of placebo injection subcutaneously.
Sponsors
Akeso
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 60 Years
Healthy volunteers
No
Inclusion criteria
1. Moderate to severe plaque-type psoriasis diagnosed for at least 6 months; 2. Subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: Body Surface Area (BSA) ≥ 10%, PASI ≥ 12 and SPGA score ≥ 3; 3. Subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator; 4. Women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug.
Exclusion criteria
1. Forms of psoriasis other than chronic plaque-type psoriasis; 2. History or evidence of active/latent tuberculosis; 3. Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening; 4. History of serious infection within 2 months before screening; 5. History of malignancy of any organ system; 6. Inadequate washout period for prior psoriatic therapy; 7. Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor; 8. Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK evaluation: Tmax | Baseline till week 20 | Assessment of time to maximum plasma concentration (Tmax) after AK111 administration. |
| Assessment of Safety | Baseline till Week 20 | Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE). |
| PK evaluation: T1/2 | Baseline till week 20 | Assessment of elimination half-life (T1/2) after AK111 administration. |
| PK evaluation: AUC | Baseline till week 20 | Assessment of area under curve (AUC) after AK111 administration. |
| PK evaluation: Cmax | Baseline till week 20 | Assessment of maximum plasma concentration (Cmax) after AK111 administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PASI 75 | At week 12 | Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 75 response which means whose PASI score decrease at least 75 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
| PASI 90 | At week 12 | Proportion of subjects who achieve PASI 90 response which means whose PASI score decrease at least 90 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
| PASI 100 | At week 12 | Proportion of subjects who achieve PASI 100 response which means whose PASI score decrease 100 percent compared with baseline at week 12. PASI is a measure of overall psoriasis severity and coverage. The PASI score is in the range of 0 (no psoriasis on the body) to 72 (the most severe case of psoriasis). |
| sPGA 0/1 | At week 12 | Proportion of subjects who achieve Static Physicians Global Assessment (sPGA) 0/1 which means whose sPGA score is clear or almost-clear at week 12. The sPGA is a measure of global assessment of the patient's overall severity, which could be converted to numerals ranging from 0 to 5 (clear = 0, almost-clear = 1, mild = 2, moderate = 3, marked = 4, and severe = 5). |
| Immunogenicity | Baseline till week 20 | Proportion of subjects with detectable anti-drug antibody (ADA). |
Countries
China
Outcome results
None listed