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

NCT05467995 | Completed Phase 2

• 1 other identifier: AK111-202
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 15

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.

Conditions

Ankylosing Spondylitis

Keywords

AK111; Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (3)

• Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.

  ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global, pain, function (assessed by BASFI) and inflammation (mean of Ankylosing Spondylitis Disease Activity Index \[BASDAI\] question 5 and 6 ). ASAS20 response is defined as improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≥1 unit in the remaining domain.

  Week16

• Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study.

  Baseline to Week20

• Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study.

  Baseline to Week20

Secondary Outcomes (11)

• Percentage of subjects who achieve SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16.

  Week 16

• Percentage of subjects who achieve ASAS20 response at each visit from baseline.

  Baseline to Week 20

• Percentage of subjects who achieve ASAS40 at each visit from baseline.

  Baseline to Week 20

• Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at each visit from baseline.

  Baseline to Week 20

• pharmacodynamics(PD) parameters: Changes of Interleukin-17A (IL-17A) level in peripheral serum compared with baseline and its relationship with AK111 exposure.

  Baseline to Week 20

Study Arms (4)

AK111 75mg

EXPERIMENTAL

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

Biological: AK111

AK111 150mg

EXPERIMENTAL

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

Biological: AK111

AK111 300mg

EXPERIMENTAL

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

Biological: AK111

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

AK111 BIOLOGICAL

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

AK111 150mg; AK111 300mg; AK111 75mg

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (15)

The first affiliated hospital of Bengbu medical college

Bengbu, Anhui, China

Location

Peking university people's hospital

Beijing, Beijing Municipality, China

Location

Peking University Shougang hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Xuanwu hospital capital medical university

Beijing, Beijing Municipality, China

Location

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The first Bethune hospital of Jilin university

Changchun, Jilin, China

Location

Second hospital of Shanxi Medical university

Taiyuan, Shanxi, China

Location

The seventh affiliated hospital, Sun Yat-sen university

Shenzhen, Shenzhen, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: July 21, 2022
• Study Start: June 2, 2021
• Primary Completion: April 25, 2022
• Study Completion: May 19, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)