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Ankylosing SpondylitisPhase 2NCT05467995

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

A Phase 2 study testing AK111 in people with Ankylosing Spondylitis, run by Akeso at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
AK111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
15 sitesChina
Study dates
2 Jun 2021to 19 May 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Peking university people's hospital

    Beijing, Beijing Municipality

  • Peking University Shougang hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • Xuanwu hospital capital medical university

    Beijing, Beijing Municipality

  • The first affiliated hospital of Bengbu medical college

    Bengbu, Anhui

  • The first Bethune hospital of Jilin university

    Changchun, Jilin

  • Guangdong provincial people's hospital

    Guangzhou, Guangdong

  • Nanfang Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • The seventh affiliated hospital, Sun Yat-sen university

    Shenzhen, Shenzhen

  • Second hospital of Shanxi Medical university

    Taiyuan, Shanxi

  • The first affiliated hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

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.

Read the 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.

Being tested
AK111, Placebo
Keywords
AK111, Ankylosing Spondylitis
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK111Biological

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

  • PlaceboBiological

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

Study groups in NCT05467995
Study groupRoleWhat they receive
AK111 75mgExperimentalAK111 75mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.
Receives: Biological: AK111
AK111 150mgExperimentalAK111 150mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.
Receives: Biological: AK111
AK111 300mgExperimentalAK111 300mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.
Receives: Biological: AK111
PlaceboPlacebo comparatorPlacebo will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week16

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

    Measured: Baseline to Week20

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

    Measured: Baseline to Week20

Secondary outcomes (11)

  1. Percentage of subjects who achieve SpondyloArthritis International Society 40% improvement (ASAS40) 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 ). ASAS40 response is defined as improvement of ≥40% and ≥2 units in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening in the remaining domain.

    Measured: Week 16

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

    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.

    Measured: Baseline to Week 20

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

    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 ). ASAS40 response is defined as improvement of ≥40% and ≥2 units in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening in the remaining domain.

    Measured: Baseline to Week 20

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

    The Ankylosing Spondylitis Quality of Life (ASQoL), a validated disease-specific 18-item questionnaire, has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with ankylosing spondylitis (AS) . The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.

    Measured: Baseline to Week 20

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

    Measured: Baseline to Week 20

  6. Immunogenicity: Number and percentage of subjects with detectable anti-AK111 antibody (ADA).

    Measured: Baseline to Week 20

  7. Change from baseline on the 36-item Short-Form (SF-36) Health Survey at each visit from baseline.

    The SF-36 is a 36-item generic health status measure. It measures 8 general health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each of the 8 domain scores and the component summary scores range from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline to Week 20

  8. Area under the curve from 0 to the time of the last quantifiable concentration (AUC0-t)

    Measured: Baseline to Week 20

  9. Maximum observed concentration (Cmax)

    Measured: Baseline to Week 20

  10. Terminal elimination half-life (T1/2)

    Measured: Baseline to Week 20

  11. Time of occurrence of Cmax (Tmax)

    Measured: Baseline to Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start2 Jun 2021
  3. Primary completion25 Apr 2022
  4. Study completion19 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467995
Sponsor's protocol ID
AK111-202
Status last verified
Mar 2024
First submitted
10 Feb 2022
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK111 in people with Ankylosing Spondylitis, run by Akeso at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16. (time frame: Week16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467995.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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