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A Study of CC-99677 in Participants With Active Ankylosing Spondylitis (AS SpA axSpA)

  • Clinicaltrials.gov identifier

    NCT04947579

  • Recruitment Status

    Recruiting

  • First Posted

    July 1, 2021

  • Last update posted

    October 25, 2021

Study Description

Brief summary:

This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.

  • Condition or Disease:Spondylitis, Ankylosing
  • Intervention/Treatment: Drug: CC-99677
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 256 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 2a Multicenter Trial of CC-99677 in Moderate-to-severe Ankylosing Spondylitis
  • Actual Study Start Date: August 2021
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: February 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of CC-99677 150 mg QD PO
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Drug: CC-99677
Oral
Experimental: Administration of CC-99677 150 mg QD PO.
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Drug: CC-99677
Oral
Experimental: Administration of CC-99677 60mg QD PO
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Drug: CC-99677
Oral
Experimental: Administration of CC-99677 60mg QD PO.
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Drug: CC-99677
Oral
Placebo Comparator: Administration of Placebo QD PO
49 participants will be randomized to placebo in biologic naive main study
Other: Placebo
Oral
Placebo Comparator: Placebo additional dose cohort
10 participants will be randomized to placebo in biologic-failure substudy
Other: Placebo
Oral

Outcome Measures

  • Primary Outcome Measures: 1. Assessment of ASAS 20 [ Time Frame: Up to week 12 ]
    The Assessment In Spondyloarthritis International Society (ASAS) 20 is defined as improvement ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.
  • Secondary Outcome Measures: 1. Assessment of ASAS 40 [ Time Frame: Up to week 12 ]
    The Assessment In Spondyloarthritis International Society (ASAS) 40 is defined as improvement ≥ 40% and ≥ 2 units on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.
  • 2. Assessment of ASDAS-CRP [ Time Frame: Up to week 12 ]
    The Ankylosing Spondylitis Disease Activity with C-reactive protein as the acute-phase reactant (ASDAS-CRP)is a validated disease activity index in AS that combines participant reported assessments of back pain, morning stiffness, joint pain and/or swelling and general wellbeing.
  • 3. Assessment of BASDAI [ Time Frame: Up to week 12 ]
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participant major symptoms of AS.
  • 4. Assessment of BASFI [ Time Frame: Up to week 12 ]
    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participant's degree of mobility and functional ability.
  • 5. SPARCC score for the total spine and sacroiliac joints [ Time Frame: Up to week 12 ]
    Spinal and sacroiliac joint inflammation as measured by Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints and spine.
  • 6. High-sensitivity C-reactive protein (hsCRP) [ Time Frame: Up to week 12 ]
    High-sensitivity C-reactive protein (hsCRP) provides an objective measure of disease activity in participants.
  • 7. Incidence of Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria Active axial disease at Screening and Baseline defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4 Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody [mAb] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS Exclusion Criteria: Radiographic evidence of total ankylosis of the spine Clinically significant back pain caused by diseases other than AS Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents Participation in any study of an investigational drug, including those for COVID-19 History of malignancy Oral corticosteroids (prednisone or equivalent) > 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, Arizona
Arizona Arthritis & Rheumatology Research - Flagstaff
Flagstaff

United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC - Gilbert
Gilbert

United States, Arizona
Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Phoenix

United States, Arizona
Arizona Arthritis & Rheumatology Research - Tucson
Tucson

United States, California
Medvin Clinical Research
Covina

United States, California
Desert Medical Advances
Palm Desert

United States, California
Robin K. Dore, MD., Inc.
Tustin

United States, Florida
Southwest Florida Clinical Research Center
Tampa

United States, Kansas
The Alliance for Multispecialty Resarch (AMR) Whichita East
Wichita

United States, Michigan
Shores Rheumatology
Saint Clair Shores

United States, New York
The Center for Rheumatology
Albany

United States, North Carolina
Joint and Muscle Research Institute
Charlotte

United States, Ohio
MetroHealth Medical Systems
Cleveland

United States, Ohio
STAT Research, Inc.
Dayton

United States, Oregon
Oregon Health and Science University - Knight Cardiovascular Institute
Portland

United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville

United States, Tennessee
West Tennessee Research Institute
Jackson

United States, Tennessee
Ramesh C Gupta MD
Memphis

United States, Texas
Austin Regional Clinic
Austin

United States, Texas
Precision Comprehensive Clinical Research Solutions
Colleyville

United States, Texas
Pioneer Research Solutions
Cypress

United States, Texas
Precision Comprehensive Clinical Research Solutions - Fort Worth
Fort Worth

United States, Texas
Southwest Rheumatology Research, LLC
Mesquite

United States, Utah
University of Utah
Salt Lake City

Canada, Alberta
University of Alberta
Edmonton

Canada, Ontario
Toronto Western Hospital
Toronto

Czechia
CCR Clinical Research Brno
Brno

Czechia
Revmaclinic
Brno

Czechia
CCR Ostrava
Ostrava

Czechia
Vesalion s.r.o.
Ostrava

Czechia
ARTHROMED s.r.o.
Pardubice

Czechia
CCR Czech as
Pardubice

Czechia
Affidea Praha s.r.o
Praha 11

Czechia
CCR Prague, s.r.o.
Praha 3

Czechia
Revmatologicka Ambulance
Praha 4

Czechia
Thomayerova Hospital
Praha 4

Czechia
Revmatologie
Praha

Czechia
Medical Plus s.r.o.
Uherské Hradište

Germany
Charite, Campus Benjamin Franklin, Medizinische Klinik III
Bielfeld

Germany
Friedrich-Alexander-Universiät Erlangen Nürnberg
Erlangen

Germany
Centrum fur innovative Diagnostik und Therapie Rheumatologie und Immunologie (CIRI)
Frankfurt am Main

Germany
Rheumazentrum Ruhrgebiet
Herne

Poland
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok

Poland
NZOZ Osteo-Medic sc A. Racewicz J. Supronik
Bialystok

Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz

Poland
Szpital Uniwersytecki nr 2 im. J.Biziela
Bydgoszcz

Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
Elblag

Poland
Silmedic Sp. z o.o.
Katowice

Poland
Malopolskie Badania Kliniczne Sp. z.o.o Sp k
Krakow

Poland
Centrum Medyczne Plejady
Krakow

Poland
Niepubliczny Zaklad Opieki Zdrowotnej REUMED
Lublin

Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sol

Poland
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan

Poland
RCMed Oddzial Sochaczew
Sochaczew

Poland
Nasz Lekarz Przychodnie Medyczne
Torun

Poland
Ars Rheumatica-Centrum Reumatologii
Warsaw

Poland
Centrum Medyczne Oporow
Wroclaw

Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov

Romania
SC Centrul Medical Sana SRL
Bucuresti

Romania
Spitalul Clinic Sfanta Maria
Bucuresti

Romania
Spitalul Clinic*
Bucuresti

Romania
Spitalul Euroclinic
Bucuresti

Russian Federation
Research Medical Complex Vashe Zdorovie
Kazan

Russian Federation
City Clinical Hospital No 7 - Kazan
Kazan

Russian Federation
Kemerovo Regional Clinical Hospital
Kemerovo

Russian Federation
LLC Medical Center Rheuma-Med
Kemerovo

Russian Federation
Klinika na Maroseyke, LLC
Moscow

Russian Federation
Orenburg Regional Clinical Hospital
Orenburg

Russian Federation
Republican Hospital na VA Baranov
Petrozavodsk

Russian Federation
State Institution of Healthcare Regional Clinical Hospital
Saratov

Russian Federation
Smolensk Regional Clinical Hospital
Smolensk

Russian Federation
City Hospital #40
St. Petersburg

Russian Federation
State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital 3
Yaroslavl

Spain
University Hospital La Coruna
A Coruña

Spain
Hospital Universitario Vall d'Hebron
Barcelona

Spain
Hospital Universitario Reina Sofia
Cordoba

Spain
Hospital de Merida
Merida

Spain
Corporacion Sanitaria Parc Tauli
Sabadell

Spain
Hospital Clinico Universitario De Santiago De Compostela
Santiago De Compostela

Spain
Hospital Virgen del Rocio Servicio de Hematologia
Sevilla

Turkey
Sakarya University
Adapazari

Turkey
Ibn Sina University Hospital (Ankara Üniversitesi İbni Sina Hastanesi)
Altındağ/Ankara

Turkey
Hacettepe Universitesi Tip Fakultesi
Ankara

Turkey
Trakya University Medical Faculty
Edirne

Turkey
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul

Turkey
Ege Universitesi Medical Faculty
Izmir

Turkey
Izmir Katip Celebi Universitesi - Ataturk Education Research Hospital
Karabaglar

Turkey
Karadeniz Teknik Universitesi
Trabzon

Sponsors and Collaborators

Celgene

Investigators

Study Director: Robert Wong, MD Celgene Corporation

More Information

  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT04947579 History of Changes
  • Other Study ID Numbers: CC-99677-AS-001, U1111-1265-3951, 2019-004108-37
  • First Posted: July 1, 2021 Key Record Dates
  • Last Update Posted: October 25, 2021
  • Last Verified: October 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Celgene: Ankylosing Spondylitis
    CC-99677
    MK2inhibitor
    Spinal Diseases
    Bone Diseases
    Musculoskeletal Diseases
    Arthritis
    Joint Diseases
  • Additional relevant MeSH terms: Spondylitis
    Spondylitis, Ankylosing
    Bone Diseases, Infectious
    Infections
    Bone Diseases
    Musculoskeletal Diseases
    Spinal Diseases
    Spondylarthropathies
    Spondylarthritis
    Ankylosis
    Joint Diseases
    Arthritis