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New hope for chinese patients with spinal arthritis: phase 3 drug trial shows promise

NCT ID NCT04732117

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called secukinumab in 137 Chinese adults with a type of spinal arthritis (non-radiographic axial spondyloarthritis) that causes back pain and stiffness. The goal was to see if the drug improves symptoms more than a placebo after 16 weeks, and to check its safety over 52 weeks. Participants received injections under the skin, and the main measure was a 40% improvement in key disease areas like pain and function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

137 people

The number who actually took part.

Started

Jul 2021

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or non-pregnant, non-nursing female patients at least 18 years of age * Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria * Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein) * Active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index \>=4 cm * Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline * Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline * Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response * Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response Exclusion Criteria: * Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally * Inability or unwillingness to undergo MRI * Chest X-ray or MRI with evidence of ongoing infectious or malignant process * Patients taking high potency opioid analgesics * Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor * Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Non-Radiographic Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-radiographic axial spondyloarthritis

Contacts and locations

Locations

  • Novartis Investigative Site

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    Hefei, Anhui, 230601, China

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044, China

  • Novartis Investigative Site

    Xiamen, Fujian, 361001, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510030, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Shantou, Guangdong, 515000, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518020, China

  • Novartis Investigative Site

    Harbin, Heilongjiang, 150000, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Changsha, Hunan, 410011, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014010, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210008, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009, China

  • Novartis Investigative Site

    Yangzhou, Jiangsu, 225001, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Pingxiang, Jiangxi, 337000, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Linyi, Shandong, 276000, China

  • Novartis Investigative Site

    Ürümqi, Xinjiang, 830001, China

  • Novartis Investigative Site

    Kunming, Yunnan, 650000, China

  • Novartis Investigative Site

    Ningbo, Zhejiang, 315016, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 100000, China

  • Novartis Investigative Site

    Beijing, 100050, China

  • Novartis Investigative Site

    Bengbu, 233004, China

  • Novartis Investigative Site

    Shanghai, 200040, China

  • Novartis Investigative Site

    Shanghai, 200050, China

  • Novartis Investigative Site

    Tianjin, 300052, China

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