A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

NCT ID: NCT05467995

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2022-05-19

Brief Summary

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. Subjects will be randomized to receive AK111 or placebo following subcutaneous injection. The study period for each subject will be 25 weeks, including a screening period of up to 35 days, followed by a treatment period of 12 weeks and a follow up period of 8 weeks.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AK111 75mg

AK111 75mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.

Group Type: EXPERIMENTAL

AK111

Intervention Type: BIOLOGICAL

AK111 administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

AK111 150mg

AK111 150mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.

Group Type: EXPERIMENTAL

AK111

Intervention Type: BIOLOGICAL

AK111 administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

AK111 300mg

AK111 300mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.

Group Type: EXPERIMENTAL

AK111

Intervention Type: BIOLOGICAL

AK111 administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

Placebo

Placebo will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

Interventions

AK111

AK111 administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

Intervention Type: BIOLOGICAL

Placebo

Placebo administered subcutaneously at Week 0, 1, and 4, then every 4 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female subjects aged 18-75 years old.
• Ankylosing spondylitis has been diagnosed for at least 6 months before screening, with radiological evidence that meets the Modified New York Criteria for Ankylosing Spondylitis.
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Spinal pain score≥ 4 (based on BASDAI question 2).
• Subjects received at least 1 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond.
• Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization.
• Subjects taking methotrexate (MTX) (≤25mg/week) or Sulfasalazine (≤3g/day) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 4 weeks before randomization.

Exclusion Criteria

• Subjects with total ankylosis of the spine.
• Subjects with progressive or uncontrolled diseases of respiratory, circulatory, digestive, urogenital, endocrine, nervous or mental systems, or with other chronic diseases that are not suitable to participate to the study.
• Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS).
• Subjects with any severe systemic or local infection within 2 months before screening.
• Subjects who are using strong opioid analgesics.
• Combined use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate and sulfasalazine, including but not limited to thalidomide, iguratimod, etc. within 4 weeks before randomization.
• Received any live vaccine within 2 months before screening or planned to receive any live vaccine during the study period.
• Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.
• Received Natalizumab or other drugs that regulate B cells or T cells within 6 months before screening.
• Received more than 2 kinds of Tumor necrosis factor alpha(TNF-α) inhibitors before screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first affiliated hospital of Bengbu medical college

Bengbu, Anhui, China

Peking university people's hospital

Beijing, Beijing Municipality, China

Peking University Shougang hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Xuanwu hospital capital medical university

Beijing, Beijing Municipality, China

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The first Bethune hospital of Jilin university

Changchun, Jilin, China

Second hospital of Shanxi Medical university

Taiyuan, Shanxi, China

The seventh affiliated hospital, Sun Yat-sen university

Shenzhen, Shenzhen, China

Countries

China

Other Identifiers

AK111-202

Identifier Type: -

Identifier Source: org_study_id