Back to resultsA Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
AK111
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
- 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;
- 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;
- 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:
- Forms of psoriasis other than chronic plaque-type psoriasis;
- History or evidence of active/latent tuberculosis;
- Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
- History of serious infection within 2 months before screening;
- History of malignancy of any organ system;
- Inadequate washout period for prior psoriatic therapy;
- Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
- Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
Sites / Locations
- AkesoBio Investigative Site 1002
- AkesoBio Investigative Site 1001
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AK111 regimen
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Assessment of Safety
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
PK evaluation: T1/2
Assessment of elimination half-life (T1/2) after AK111 administration.
PK evaluation: AUC
Assessment of area under curve (AUC) after AK111 administration.
PK evaluation: Cmax
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
PK evaluation: Tmax
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
Secondary Outcome Measures
PASI 75
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
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
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
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
Proportion of subjects with detectable anti-drug antibody (ADA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05504317
Brief Title
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AK111 regimen
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AK111
Intervention Description
Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive corresponding dose of placebo injection subcutaneously.
Primary Outcome Measure Information:
Title
Assessment of Safety
Description
Incidence of treatment emergent adverse events (TEAE), serious adverse events (SAE).
Time Frame
Baseline till Week 20
Title
PK evaluation: T1/2
Description
Assessment of elimination half-life (T1/2) after AK111 administration.
Time Frame
Baseline till week 20
Title
PK evaluation: AUC
Description
Assessment of area under curve (AUC) after AK111 administration.
Time Frame
Baseline till week 20
Title
PK evaluation: Cmax
Description
Assessment of maximum plasma concentration (Cmax) after AK111 administration.
Time Frame
Baseline till week 20
Title
PK evaluation: Tmax
Description
Assessment of time to maximum plasma concentration (Tmax) after AK111 administration.
Time Frame
Baseline till week 20
Secondary Outcome Measure Information:
Title
PASI 75
Description
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).
Time Frame
At week 12
Title
PASI 90
Description
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).
Time Frame
At week 12
Title
PASI 100
Description
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).
Time Frame
At week 12
Title
sPGA 0/1
Description
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).
Time Frame
At week 12
Title
Immunogenicity
Description
Proportion of subjects with detectable anti-drug antibody (ADA).
Time Frame
Baseline till week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate to severe plaque-type psoriasis diagnosed for at least 6 months;
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;
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;
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:
Forms of psoriasis other than chronic plaque-type psoriasis;
History or evidence of active/latent tuberculosis;
Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening;
History of serious infection within 2 months before screening;
History of malignancy of any organ system;
Inadequate washout period for prior psoriatic therapy;
Previous use of secukinumab, ixekizumab or any other drug that targets IL-17 or IL-17 receptor;
Any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
Facility Information:
Facility Name
AkesoBio Investigative Site 1002
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
AkesoBio Investigative Site 1001
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
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