Clinical Trial Details

NCT ID: NCT02963506
Date Last Changed: June 22, 2017

Overview

Research Study Summary

A clinical research study of Placebo and Bimekizumab for the treatment of Ankylosing Spondylitis

Research Study Title

A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

Purpose

This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
UCB Biopharma S.P.R.L.
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for > =3 months and age of onset < 45 years

  • Subject has moderate to severe active disease as defined by each of the following:

  • BASDAI score > =4

  • Spinal pain > =4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)

  • Subjects must have at least 1 of the following:

  • inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy

  • intolerance to administration of at least 1 NSAID

  • contraindication(s) to NSAID therapy

  • Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline

  • Subjects taking corticosteroids must be on an average daily dose of < =10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16

  • Subjects taking methotrexate (MTX) ( < =25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization

  • Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization

  • Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

  • experienced an inadequate response to previous treatment given for at least 3 months

  • been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)

  • lost access to TNF inhibitor for other reasons

Exclusion Criteria:

  • Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis

  • Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)

  • Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit

  • Subjects receiving any live vaccination within the 8 weeks prior to Baseline

  • Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection

  • Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:

  • < = 3 excised or ablated basal cell carcinomas of the skin

  • One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening

  • Actinic keratosis (-es)

  • Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Site Locations (87)

Country State City Zip Facility and Contact
United States Alabama Anniston As0008 019
United States California San Diego As0008 007
United States California San Francisco As0008 024
United States California Upland As0008 009
United States Florida Aventura As0008 005
United States Florida Fort Lauderdale As0008 017
United States Florida Ormond Beach As0008 022
United States Florida Sarasota As0008 030
United States Florida Venice As0008 032
United States Massachusetts Boston As0008 027
United States Minnesota Eagan As0008 016
United States New Jersey Freehold As0008 021
United States Ohio Cleveland As0008 015
United States Oregon Portland As0008 014
United States Pennsylvania Duncansville As0008 001
United States South Carolina Charleston As0008 004
United States Texas Austin As0008 020
United States Texas Dallas As0008 006
United States Texas Dallas As0008 023
United States Texas Houston As0008 018
United States Washington Seattle As0008 002
Bulgaria Dobrich As0008 156
Bulgaria Pleven As0008 153
Bulgaria Plovdiv As0008 151
Bulgaria Plovdiv As0008 154
Bulgaria Plovdiv As0008 155
Bulgaria Ruse As0008 150
Bulgaria Sofia As0008 159
Canada Quebec As0008 101
Canada Victoria As0008 100
Canada Winnipeg As0008 103
Czechia Brno As0008 205
Czechia Hustopece As0008 206
Czechia Olomouc As0008 207
Czechia Pardubice As0008 208
Czechia Prague 4 As0008 200
Czechia Praha 11 As0008 210
Czechia Praha 2 As0008 202
Czechia Praha 4 As0008 201
Czechia Praha 4 As0008 209
Czechia Praha As0008 211
Czechia Ziln As0008 203
Germany Berlin As0008 305
Germany Cologne As0008 302
Germany Erlangen As0008 309
Germany Hamburg As0008 304
Germany Hannover As0008 309
Germany Herne As0008 303
Germany Ratinen As0008 301
Hungary Budapest As0008 400
Hungary Budapest As0008 403
Hungary Debrecen As0008 402
Hungary Veszprem As0008 401
Poland Bydgoszcz As0008 466
Poland Elblag As0008 453
Poland Elblag As0008 456
Poland Krakow As0008 455
Poland Lublin As0008 461
Poland Nowa Sol As0008 467
Poland Poznan As0008 451
Poland Poznan As0008 462
Poland Torun As0008 450
Poland Warszawa As0008 454
Poland Warszawa As0008 459
Poland Wroclaw As0008 457
Poland Wroclaw As0008 460
Poland Wroclaw As0008 465
Russian Federation Moscow As0008 601
Russian Federation Moscow As0008 604
Russian Federation Moscow As0008 605
Russian Federation Moscow As0008 607
Russian Federation Saint Petersburg As0008 600
Russian Federation Saint Petersburg As0008 606
Russian Federation Saint Petersburg As0008 608
Russian Federation Saint Petersburg As0008 609
Russian Federation Saint Petersburg As0008 610
Spain Cordoba As0008 800
Spain La Coruna As0008 801
Spain Madrid As0008 802
Spain Madrid As0008 804
Spain Santiago de Compostela As0008 803
Ukraine Kiev As0008 700
Ukraine Kyiv As0008 707
Ukraine Ternopil As0008 705
Ukraine Urhgorod As0008 708
Ukraine Vinnytsya As0008 706
Ukraine Zaporizhya As0008 704

Contact

UCB Cares
+1 844 599 ext. 2273
E-mail:

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