Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis
- Summary
- This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.
- Short title
- Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis
- Official title
- An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2023-11-24
- First posted
- 2022-08-22
- Registry last updated
- 2024-06-04
- Primary completion date
- 2023-11-24
- Start date
- 2022-04-08
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Akeso
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05509361
- ClinicalTrials.gov ID
- NCT05509361
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Occurrence of Treatment-Emergent Adverse Event
Timeframe: up to 52 weeks
To evaluate long-term safety as assessed by occurrence of TEAE.
Occurrence of Serious Adverse Event and Adverse Events of Special Interest
Timeframe: up to 52 weeks
To evaluate long-term safety as assessed by occurrence of SAE and AESI.
Percentage of Subjects Who Achieved at least 50% (PASI 50), 75% (PASI 75) and 90% (PASI 90) Reduction in Psoriasis Area and Severity Index (PASI) Score
Timeframe: up to 52 weeks
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.
Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)
Timeframe: up to 52 weeks
The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe.
Pharmacokinetics Assessment of AK101 Serum Concentration
Timeframe: up to 52 weeks
Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)
Timeframe: up to 52 weeks
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
-
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
- Subjects can continue to participate in this study based on assessment of investigator.
- Subjects voluntarily participate in this study.
- Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the treatment period and for at least 6 months after the last study drug administration.
-
Applicable for subjects newly enrolled:
- Male or female subjects aged ≥ 18 years old.
- Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment.
- At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
- Subjects who are applicable for biological agents, based on the assessment of investigator.
- Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration.
Key Exclusion Criteria:
-
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
- Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection.
- Subjects who used prohibited drugs in an Akeso trial with AK101 injection.
- Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator.
- Subjects with any other disease, abnormal physical examination or abnormal laboratory examination leading to inapplicable for participating this study, based on the assessment of investigator.
-
Applicable for subjects newly enrolled:
- Forms of psoriasis other than chronic plaque-type psoriasis.
- History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
- Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
- History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
- History of prohibited psoriasis treatments within 2/4 weeks before randomization.
- History of IL-12/23 or IL-23 inhibitors therapy.
- Inadequate washout period of prior biological therapy.
- History of malignant tumour within 5 years before screening.
- Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.
- Peking university people's hospitalBeijing, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Psoriasis Primary condition