Spondylitis, Ankylosing

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody

1794%

Small Molecule

16%

+ 9 programs with unclassified modality

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Sharp TherapeuticsPA - Pittsburgh

8 programs

InfliximabPhase 4Monoclonal Antibody1 trial

PDUSPhase 41 trial

RemicadePhase 41 trial

GolimumabPhase 3Monoclonal Antibody1 trial

+3 more programs

Active Trials

NCT00818168Completed320Est. Dec 2010

NCT00725543Completed358Est. Jun 2010

NCT01453725Completed198Est. Jan 2015

+5 more trials

MSDIreland - Ballydine

8 programs

InfliximabPhase 4Monoclonal Antibody

PDUSPhase 4

RemicadePhase 4

GolimumabPhase 3Monoclonal Antibody

+3 more programs

SandozAustria - Kundl

3 programs

SecukinumabPhase 3Monoclonal Antibody1 trial

Active Trials

NCT01863732Completed274Est. Mar 2018

NCT02008916Completed226Est. Dec 2017

NCT02159053Completed350Est. Jan 2018

PfizerNEW YORK, NY

1 program

CelecoxibPhase 3Small Molecule1 trial

Active Trials

NCT00648141Completed458Est. Jan 2005

Prevail TherapeuticsNY - New York

1 program

IxekizumabPhase 3Monoclonal Antibody1 trial

Active Trials

NCT01870284Withdrawn0Est. Apr 2018

RocheSTAVANGER NORWAY, Norway

2 programs

TocilizumabPHASE_3Monoclonal Antibody

tocilizumabPHASE_3Monoclonal Antibody

UNION therapeuticsDenmark - Hellerup

1 program

A Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing SpondylitisN/A1 trial

Active Trials

NCT01901627Unknown400Est. Jun 2015

Merck & Co.RAHWAY, NJ

1 program

InfliximabN/AMonoclonal Antibody

Integrated BiosciencesCA - San Carlos

1 program

tapering or discontinuation of etanerceptN/A1 trial

Active Trials

NCT03880968Completed311Est. Sep 2014

Boehringer IngelheimINGELHEIM, Germany

1 program

Meloxicam suppositoryPHASE_31 trial

Active Trials

NCT02183168Completed192

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Sharp TherapeuticsPDUS

Sharp TherapeuticsRemicade

Sharp TherapeuticsInfliximab

SandozSecukinumab

Prevail TherapeuticsIxekizumab

SandozSecukinumab

Sharp TherapeuticsGolimumab

Sharp Therapeuticsinfliximab

PfizerCelecoxib

Boehringer IngelheimMeloxicam suppository

UNION therapeuticsA Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing Spondylitis

Integrated Biosciencestapering or discontinuation of etanercept

Sharp TherapeuticsInfliximab

Showing 15 of 16 trials with date data

Clinical Trials (16)

Total enrollment: 3,266 patients across 16 trials

NCT00686894 Sharp TherapeuticsPDUS

Enthesitis With Ultra Sonography Doppler in Spondyloarthropathies Treated With Infliximab (Study P04440)

Start: Jan 2008Est. completion: Nov 20087 patients

Phase 4Terminated

NCT00778869 Sharp TherapeuticsRemicade

Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)

Start: Aug 2005Est. completion: Aug 200510 patients

Phase 4Completed

NCT00779935 Sharp TherapeuticsRemicade

Growth Factor Concentration to Predict an Ankylosing Spondylitis Patient's Response to Infliximab (Study P04041)(COMPLETED)

Start: Oct 2004Est. completion: Feb 200744 patients

Phase 4Completed

NCT00779012 Sharp TherapeuticsInfliximab

A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

Start: Oct 2004Est. completion: Jun 200742 patients

Phase 4Completed

NCT02159053 SandozSecukinumab

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

Start: May 2015Est. completion: Jan 2018350 patients

Phase 3Completed

NCT01870284 Prevail TherapeuticsIxekizumab

Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

Start: Jul 2014Est. completion: Apr 20180

Phase 3Withdrawn

NCT02008916 SandozSecukinumab

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Start: Jan 2014Est. completion: Dec 2017226 patients

Phase 3Completed

NCT01863732 SandozSecukinumab

Extension in AS: Sustainability of Benefits, Safety and Tolerability

Start: Nov 2013Est. completion: Mar 2018274 patients

Phase 3Completed

NCT01453725 Sharp TherapeuticsGolimumab

Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)

Start: Feb 2012Est. completion: Jan 2015198 patients

Phase 3Completed

NCT00202865 Sharp Therapeuticsinfliximab

Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)

Start: May 2005Est. completion: May 200776 patients

Phase 3Completed

NCT00648141 PfizerCelecoxib

Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Start: Jan 2003Est. completion: Jan 2005458 patients

Phase 3Completed

NCT02183168 Boehringer IngelheimMeloxicam suppository

Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis

Start: Jul 2001192 patients

Phase 3Completed

NCT01901627 UNION therapeuticsA Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing Spondylitis

A Multicenter Registry of Adalimumab in Chinese Adult Patients With Active Ankylosing Spondylitis

Start: Apr 2013Est. completion: Jun 2015400 patients

N/AUnknown

NCT03880968 Integrated Biosciencestapering or discontinuation of etanercept

Treat-to-Target Strategy With Etanercept for Ankylosing Spondylitis

Start: Mar 2012Est. completion: Sep 2014311 patients

N/ACompleted

NCT00725543 Sharp TherapeuticsInfliximab

Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

Start: Jun 2004Est. completion: Jun 2010358 patients

N/ACompleted

NCT00818168 Sharp TherapeuticsInfliximab

Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)

Start: Jul 2003Est. completion: Dec 2010320 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

9 late-stage (Phase 3) programs, potential near-term approvals

Monoclonal Antibody is the dominant modality (94% of programs)

11 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.