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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04947579 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Celgene |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb, MD |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Canada, China, Czechia, Germany, Poland, Romania, Russian Federation, Spain, Turkey, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Spondylitis, Ankylosing |
Study Website: | View Trial Website |
Experimental: Administration of CC-99677 150 mg QD PO
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Experimental: Administration of CC-99677 60mg QD PO
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Placebo Comparator: Administration of Placebo QD PO
49 participants will be randomized to placebo in biologic naive main study
Experimental: Administration of CC-99677 150 mg QD PO.
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Experimental: Administration of CC-99677 60mg QD PO.
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Placebo Comparator: Placebo additional dose cohort
10 participants will be randomized to placebo in biologic-failure substudy
Drug: - CC-99677
Oral
Other: - Placebo
Oral
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
Arizona Arthritis & Rheumatology Research - Flagstaff
Flagstaff, Arizona, 86001
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research - Flagstaff
Flagstaff, Arizona, 86001
Status
Not yet recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC - Gilbert
Gilbert, Arizona, 58297
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC - Gilbert
Gilbert, Arizona, 58297
Status
Not yet recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Phoenix, Arizona, 95037
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Phoenix, Arizona, 95037
Status
Not yet recruiting
Address
Arizona Arthritis & Rheumatology Research - Tucson
Tucson, Arizona, 85704
Status
Recruiting
Address
Arizona Arthritis & Rheumatology Research - Tucson
Tucson, Arizona, 85704
Status
Not yet recruiting
Address
Medvin Clinical Research
Covina, California, 91723
Status
Withdrawn
Address
Medvin Clinical Research
Covina, California, 91723
Status
Not yet recruiting
Address
Desert Medical Advances
Palm Desert, California, 92260
Status
Withdrawn
Address
Desert Medical Advances
Palm Desert, California, 92260
Status
Active, not recruiting
Address
Local Institution - 017
Tustin, California, 92780
Status
Not yet recruiting
Address
Robin K. Dore, MD., Inc.
Tustin, California, 92780
Status
Not yet recruiting
Address
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Status
Withdrawn
Address
Southwest Florida Clinical Research Center
Tampa, Florida, 33609
Status
Not yet recruiting
Address
The Alliance for Multispecialty Resarch (AMR) Whichita East
Wichita, Kansas, 67207
Status
Withdrawn
Address
The Alliance for Multispecialty Resarch (AMR) Whichita East
Wichita, Kansas, 67207
Status
Not yet recruiting
Address
Shores Rheumatology
Saint Clair Shores, Michigan, 48081
Status
Recruiting
Address
Shores Rheumatology
Saint Clair Shores, Michigan, 48081
Status
Not yet recruiting
Address
The Center for Rheumatology
Albany, New York, 12203
Status
Withdrawn
Address
The Center for Rheumatology
Albany, New York, 12203
Status
Not yet recruiting
Address
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Status
Withdrawn
Address
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204
Status
Recruiting
Address
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Status
Not yet recruiting
Address
MetroHealth Medical Systems
Cleveland, Ohio, 44109
Status
Not yet recruiting
Address
STAT Research, Inc.
Dayton, Ohio, 45417
Status
Recruiting
Address
STAT Research, Inc.
Dayton, Ohio, 45417
Status
Not yet recruiting
Address
Oregon Health and Science University - Knight Cardiovascular Institute
Portland, Oregon, 97239
Status
Recruiting
Address
Oregon Health and Science University - Knight Cardiovascular Institute
Portland, Oregon, 97239
Status
Recruiting
Address
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Status
Recruiting
Address
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Status
Recruiting
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Recruiting
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Recruiting
Address
Ramesh C Gupta MD
Memphis, Tennessee, 38119
Status
Recruiting
Address
Ramesh C Gupta MD
Memphis, Tennessee, 38119
Status
Recruiting
Address
Austin Regional Clinic
Austin, Texas, 78731
Status
Recruiting
Address
Austin Regional Clinic
Austin, Texas, 78731
Status
Recruiting
Address
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Status
Recruiting
Address
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 76034
Status
Recruiting
Address
Precision Comprehensive Clinical Research Solutions - Fort Worth
Fort Worth, Texas, 76107
Status
Active, not recruiting
Address
Precision Comprehensive Clinical Research Solutions - Fort Worth
Fort Worth, Texas, 76107
Status
Not yet recruiting
Address
Pioneer Research Solutions
Houston, Texas, 77099
Status
Not yet recruiting
Address
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150
Status
Withdrawn
Address
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150
Status
Not yet recruiting
Address
University of Utah
Salt Lake City, Utah, 84132
Status
Withdrawn
Address
University Of Utah
Salt Lake City, Utah, 84132
Status
Not yet recruiting
Address
University of Alberta
Edmonton, Alberta, T6G1Z1
Status
Not yet recruiting
Address
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Status
Active, not recruiting
Address
Local Institution - 154
Shanghai, Shanghai, 200040
Status
Active, not recruiting
Address
Local Institution - 151
Guangzhou, , 510630
Status
Active, not recruiting
Address
Local Institution - 152
Hangzhou, , 310014
Status
Active, not recruiting
Address
Local Institution - 153
Huangpu District, , 200000
Status
Active, not recruiting
Address
Local Institution - 150
Wuhan, , 430030
Status
Not yet recruiting
Address
CCR Clinical Research Brno
Brno, , 602 00
Status
Withdrawn
Address
Local Institution - 200
Brno, , 602 00
Status
Recruiting
Address
Local Institution - 205
Brno, , 61141
Status
Not yet recruiting
Address
Revmaclinic
Brno, , 61141
Status
Recruiting
Address
Local Institution - 206
Ostrava, , 702 00
Status
Recruiting
Address
Local Institution - 207
Ostrava, , 702 00
Status
Recruiting
Address
Vesalion s.r.o.
Ostrava, , 702 00
Status
Not yet recruiting
Address
ARTHROMED s.r.o.
Pardubice, , 530 02
Status
Not yet recruiting
Address
CCR Czech as
Pardubice, , 530 02
Status
Recruiting
Address
Local Institution - 201
Pardubice, , 530 02
Status
Not yet recruiting
Address
Affidea Praha s.r.o
Praha 11, , 148 00
Status
Recruiting
Address
Local Institution - 211
Praha 11, , 148 00
Status
Not yet recruiting
Address
CCR Prague, s.r.o.
Praha 3, , 13000
Status
Recruiting
Address
Local Institution - 202
Praha 3, , 13000
Status
Recruiting
Address
Local Institution - 203
Praha 4, , 140 00
Status
Not yet recruiting
Address
Revmatologicka Ambulance
Praha 4, , 140 00
Status
Not yet recruiting
Address
Thomayerova Hospital
Praha 4, , 140 00
Status
Withdrawn
Address
Local Institution - 209
Praha, , 140 00
Status
Not yet recruiting
Address
Revmatologie
Praha, , 140 00
Status
Recruiting
Address
Local Institution - 204
Uherské Hradište, , 686 01
Status
Not yet recruiting
Address
Medical Plus s.r.o.
Uherské Hradište, , 686 01
Status
Not yet recruiting
Address
Charite, Campus Benjamin Franklin, Medizinische Klinik III
Bielfeld, , 33647
Status
Not yet recruiting
Address
Friedrich-Alexander-Universiät Erlangen Nürnberg
Erlangen, , 91054
Status
Not yet recruiting
Address
Centrum fur innovative Diagnostik und Therapie Rheumatologie und Immunologie (CIRI)
Frankfurt am Main, , 60590
Status
Withdrawn
Address
Local Institution - 901
Frankfurt am Main, , 60590
Status
Recruiting
Address
Local Institution - 900
Herne, , 44649
Status
Recruiting
Address
Rheumazentrum Ruhrgebiet
Herne, , 44649
Status
Recruiting
Address
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , 15-077
Status
Recruiting
Address
Local Institution - 311
Bialystok, , 15-077
Status
Recruiting
Address
Local Institution - 315
Bialystok, , 15-351
Status
Recruiting
Address
NZOZ Osteo-Medic sc A. Racewicz J. Supronik
Bialystok, , 15-351
Status
Recruiting
Address
Local Institution - 305
Bydgoszcz, , 85-065
Status
Recruiting
Address
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , 85-065
Status
Recruiting
Address
Local Institution - 302
Bydgoszcz, , 85-168
Status
Recruiting
Address
Szpital Uniwersytecki nr 2 im. J.Biziela
Bydgoszcz, , 85-168
Status
Recruiting
Address
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
Elblag, , 82-300
Status
Recruiting
Address
Local Institution - 301
Elblag, , 82-300
Status
Recruiting
Address
Local Institution - 307
Katowice, , 40-282
Status
Recruiting
Address
Silmedic Sp. z o.o.
Katowice, , 40-282
Status
Recruiting
Address
Local Institution - 300
Krakow, , 30-002
Status
Recruiting
Address
Malopolskie Badania Kliniczne Sp. z.o.o Sp k
Krakow, , 30-002
Status
Recruiting
Address
Centrum Medyczne Plejady
Krakow, , 30-363
Status
Recruiting
Address
Local Institution - 308
Krakow, , 30-363
Status
Recruiting
Address
Local Institution - 310
Nowa Sol, , 67-100
Status
Recruiting
Address
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sol, , 67-100
Status
Recruiting
Address
Local Institution - 313
Onyksowa 10, , 20-582
Status
Recruiting
Address
Niepubliczny Zaklad Opieki Zdrowotnej REUMED
Onyksowa 10, , 20-582
Status
Not yet recruiting
Address
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan, , 61-397
Status
Recruiting
Address
Local Institution - 312
Sochaczew, , 96-500
Status
Recruiting
Address
RCMed Oddzial Sochaczew
Sochaczew, , 96-500
Status
Recruiting
Address
Local Institution - 306
Torun, , 87-100
Status
Recruiting
Address
Nasz Lekarz Przychodnie Medyczne
Torun, , 87-100
Status
Recruiting
Address
Ars Rheumatica-Centrum Reumatologii
Warsaw, , 02-691
Status
Recruiting
Address
Local Institution - 303
Warsaw, , 02-691
Status
Recruiting
Address
Centrum Medyczne Oporow
Wroclaw, , 52-416
Status
Recruiting
Address
Local Institution - 309
Wroclaw, , 52-416
Status
Not yet recruiting
Address
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, , 500283
Status
Recruiting
Address
Local Institution - 400
Brasov, , 500283
Status
Recruiting
Address
Local Institution - 404
Bucuresti, , 011025
Status
Not yet recruiting
Address
SC Centrul Medical Sana SRL
Bucuresti, , 011025
Status
Recruiting
Address
Local Institution - 402
Bucuresti, , 011172
Status
Recruiting
Address
Local Institution - 403
Bucuresti, , 011172
Status
Not yet recruiting
Address
Spitalul Clinic Sfanta Maria
Bucuresti, , 011172
Status
Not yet recruiting
Address
Spitalul Clinic*
Bucuresti, , 011172
Status
Withdrawn
Address
Local Institution - 401
Bucuresti, , 14461
Status
Not yet recruiting
Address
Spitalul Euroclinic
Bucuresti, , 14461
Status
Withdrawn
Address
Local Institution - 506
Kazan, , 420097
Status
Withdrawn
Address
Research Medical Complex Vashe Zdorovie
Kazan, , 420097
Status
Withdrawn
Address
City Clinical Hospital No 7 - Kazan
Kazan, , 420103
Status
Withdrawn
Address
Local Institution - 501
Kazan, , 420103
Status
Withdrawn
Address
Kemerovo Regional Clinical Hospital
Kemerovo, , 650066
Status
Withdrawn
Address
Local Institution - 509
Kemerovo, , 650066
Status
Withdrawn
Address
LLC Medical Center Rheuma-Med
Kemerovo, , 650070
Status
Withdrawn
Address
Local Institution - 507
Kemerovo, , 650070
Status
Withdrawn
Address
Klinika na Maroseyke, LLC
Moscow, , 101000
Status
Withdrawn
Address
Local Institution - 500
Orenburg, , 460018
Status
Withdrawn
Address
Orenburg Regional Clinical Hospital
Orenburg, , 460018
Status
Withdrawn
Address
Republican Hospital na VA Baranov
Petrozavodsk, , 185019
Status
Withdrawn
Address
State Institution of Healthcare Regional Clinical Hospital
Saratov, , 410053
Status
Withdrawn
Address
Local Institution - 504
Smolensk, , 214018
Status
Withdrawn
Address
Smolensk Regional Clinical Hospital
Smolensk, , 214018
Status
Withdrawn
Address
City Hospital #40
St. Petersburg, , 197706
Status
Withdrawn
Address
Local Institution - 508
St. Petersburg, , 197706
Status
Withdrawn
Address
State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital 3
Yaroslavl, , 150007
Status
Active, not recruiting
Address
Local Institution - 604
A Coruña, , 15006
Status
Recruiting
Address
University Hospital La Coruna
A Coruña, , 15006
Status
Not yet recruiting
Address
Hospital Universitario Vall d'Hebron
Barcelona, , 08035
Status
Active, not recruiting
Address
Local Institution - 607
Barcelona, , 08035
Status
Recruiting
Address
Hospital Universitario Reina Sofia
Cordoba, , 14001
Status
Active, not recruiting
Address
Local Institution - 606
Cordoba, , 14001
Status
Recruiting
Address
Hospital de Merida
Merida, , 06800
Status
Active, not recruiting
Address
Local Institution - 605
Merida, , 06800
Status
Recruiting
Address
Corporacion Sanitaria Parc Tauli
Sabadell, , 8208
Status
Active, not recruiting
Address
Local Institution - 601
Sabadell, , 8208
Status
Recruiting
Address
Hospital Clinico Universitario De Santiago De Compostela
Santiago De Compostela, , 15706
Status
Active, not recruiting
Address
Local Institution - 602
Santiago De Compostela, , 15706
Status
Recruiting
Address
Hospital Virgen del Rocio Servicio de Hematologia
Sevilla, , 41013
Status
Active, not recruiting
Address
Local Institution - 603
Sevilla, , 41013
Status
Active, not recruiting
Address
Local Institution - 702
Adapazari, , 54100
Status
Recruiting
Address
Sakarya University
Adapazari, , 54100
Status
Recruiting
Address
Ibn Sina University Hospital (Ankara Üniversitesi İbni Sina Hastanesi)
Altındağ/Ankara, , 06230
Status
Active, not recruiting
Address
Local Institution - 707
Altındağ/Ankara, , 06230
Status
Recruiting
Address
Hacettepe Universitesi Tip Fakultesi
Ankara, , 06100
Status
Active, not recruiting
Address
Local Institution - 700
Ankara, , 06100
Status
Active, not recruiting
Address
Local Institution - 701
Edirne, , 22030
Status
Recruiting
Address
Trakya University Medical Faculty
Edirne, , 22030
Status
Not yet recruiting
Address
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul, , 34098
Status
Active, not recruiting
Address
Local Institution - 705
Istanbul, , 34098
Status
Not yet recruiting
Address
Ege Universitesi Medical Faculty
Izmir, , 35100
Status
Active, not recruiting
Address
Local Institution - 706
Izmir, , 35100
Status
Not yet recruiting
Address
Izmir Katip Celebi Universitesi - Ataturk Education Research Hospital
Karabaglar, , 35360
Status
Active, not recruiting
Address
Local Institution - 704
Karabaglar, , 35360
Status
Recruiting
Address
Karadeniz Teknik Universitesi
Trabzon, , 61080
Status
Active, not recruiting
Address
Local Institution - 703
Trabzon, , 61080