Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis

NCT05509361 | Completed Phase 3

• 1 other identifier: AK101-303
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment-Emergent Adverse Event

  To evaluate long-term safety as assessed by occurrence of TEAE.

  up to 52 weeks

Secondary Outcomes (5)

• Occurrence of Serious Adverse Event and Adverse Events of Special Interest

  up to 52 weeks

• 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

  up to 52 weeks

• Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)

  up to 52 weeks

• Pharmacokinetics Assessment of AK101 Serum Concentration

  up to 52 weeks

• Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)

  up to 52 weeks

Study Arms (1)

AK101 135mg

EXPERIMENTAL

Subjects who have completed AK101-302 receive AK101 135mg injection subcutaneously every 12 weeks. Subjects newly enrolled receive AK101 135mg injection subcutaneously at Week 0, 4 and then every 12 weeks.

Biological: AK101 injection SC

Interventions

AK101 injection SC BIOLOGICAL

AK101 is supplied as 135 mg doses, provided in 1 mL prefilled syringes.

AK101 135mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Peking university people's hospital

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: April 8, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)