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

NCT ID: NCT05509361

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2023-11-24

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.

Detailed Description

This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK101 135mg

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.

Group Type: EXPERIMENTAL

AK101 injection SC

Intervention Type: BIOLOGICAL

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

Interventions

AK101 injection SC

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:

1. Subjects can continue to participate in this study based on assessment of investigator.

2. Subjects voluntarily participate in this study.

3. 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:

1. Male or female subjects aged ≥ 18 years old.

2. Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment.

3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.

4. Subjects who are applicable for biological agents, based on the assessment of investigator.

5. 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.

Exclusion Criteria

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:

1. Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection.

2. Subjects who used prohibited drugs in an Akeso trial with AK101 injection.

3. Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator.

4. 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:

1. Forms of psoriasis other than chronic plaque-type psoriasis.

2. 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.

3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.

4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.

5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.

6. History of IL-12/23 or IL-23 inhibitors therapy.

7. Inadequate washout period of prior biological therapy.

8. History of malignant tumour within 5 years before screening.

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking university people's hospital

Beijing, , China

Countries

China

Other Identifiers

AK101-303

Identifier Type: -

Identifier Source: org_study_id