Phase 3 N=317 Randomized Quadruple-blind Treatment

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

Axial Spondyloarthritis · Nonradiographic Axial Spondyloarthritis · Nr-axSpA

Bottom Line

View on ClinicalTrials.gov: NCT02552212 ↗

Enrolled (actual)

317

Serious AEs

4.6%

Results posted

Aug 2020

Primary outcome: Primary: Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52 — 7.0; 47.2 percentage of subjects — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Certolizumab Pegol (Biological); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB BIOSCIENCES GmbH
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52	7.0; 47.2	<0.001 sig
PRIMARY Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12	11.4; 47.8	<0.001 sig
PRIMARY Certolizumab Pegol Plasma Concentration at Baseline	—	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 1	50.5	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 2	36.4	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 4	54.6; 48.8	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 12	29.1; 30.5	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 24	23.5; 24.8	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 36	24.0; 22.9	—
PRIMARY Certolizumab Pegol Plasma Concentration at Week 52	22.6	—
PRIMARY Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit	0.2; NA	—
SECONDARY Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52	15.8; 56.6	<0.001 sig
SECONDARY Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)	-0.38; -2.07	<0.001 sig
SECONDARY Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)	-1.44; -3.03	<0.0001 sig
SECONDARY Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-0.91; -2.73	<0.001 sig
SECONDARY Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-2.59; -3.88	<0.001 sig
SECONDARY Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score	0.200; -4.669	<0.001 sig
SECONDARY Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52	48; 115	<0.001 sig
SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52	-0.18; -0.36	<0.001 sig
SECONDARY Change From Baseline in ASQoL at Week 1	-0.03; -0.11	—
SECONDARY Change From Baseline in ASQoL at Week 2	-0.03; -0.16	—
SECONDARY Change From Baseline in ASQoL at Week 4	-0.06; -0.18	—
SECONDARY Change From Baseline in ASQoL at Week 12	-0.08; -0.28	—
SECONDARY Change From Baseline in ASQoL at Week 24	-0.09; -0.31	—
SECONDARY Change From Baseline in ASQoL at Week 36	-0.11; -0.33	—
SECONDARY Change From Baseline in ASQoL at Week 48	-0.10; -0.34	—
SECONDARY Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52	-2.1; -4.0	<0.001 sig
SECONDARY Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52	8; 4	=0.247
SECONDARY Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study	63.9; 75.5; 59.4; 65.0; 61.3	—
SECONDARY Percentage of Subjects With Serious Adverse Events (SAEs) During the Study	2.5; 5.0; 3.1; 5.0; 6.2	—
SECONDARY Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	1.9; 1.9; 3.1; 0; 2.5	—

Summary

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.

Eligibility Criteria

Inclusion Criteria

At least 18 years old at the start of Screening Visit
A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
Subjects must have had back pain for at least 12 months before Screening
No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays
Active disease at Screening as defined by
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)
Inadequate response to, have a contraindication to, or have been intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria

Diagnosis of AS or any other Inflammatory Arthritis
Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to TNF antagonist therapy
History of or current chronic or recurrent infections
Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent Tuberculosis (LTB)
Recent live vaccination
Concurrent malignancy or a history of malignancy
Class III or IV congestive heart failure - New York Heart Association (NYHA)
Demyelinating disease of the central nervous system
Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02552212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.