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

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04947579

Collaborator

(none)

256

Enrollment

120

Locations

Arms

29.7

Anticipated Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Spondylitis, Ankylosing	Drug: CC-99677 Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis

Actual Study Start Date :

Aug 25, 2021

Anticipated Primary Completion Date :

Nov 22, 2023

Anticipated Study Completion Date :

Feb 14, 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 60mg QD PO 49 participants will be randomized to CC-99677 60 mg in biologic naive main study	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
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. 20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy	Drug: CC-99677 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

Assessment of ASAS 20 [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

Assessment of ASAS 40 [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.
Assessment of ASDAS-CRP [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.
Assessment of BASDAI [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.
Assessment of BASFI [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.
SPARCC score for the total spine and sacroiliac joints [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.
High-sensitivity C-reactive protein (hsCRP) [Up to week 12]
High-sensitivity C-reactive protein (hsCRP) provides an objective measure of disease activity in participants.
Incidence of Adverse Events (AEs) [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

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arthritis & Rheumatology Research - Flagstaff	Flagstaff	Arizona	United States	86001
2	Arizona Arthritis & Rheumatology Research, PLLC - Gilbert	Gilbert	Arizona	United States	58297
3	Arizona Arthritis & Rheumatology Research, PLLC - Phoenix	Phoenix	Arizona	United States	95037
4	Arizona Arthritis & Rheumatology Research - Tucson	Tucson	Arizona	United States	85704
5	Medvin Clinical Research	Covina	California	United States	91723
6	Desert Medical Advances	Palm Desert	California	United States	92260
7	Desert Medical Advances	Palm Desert	California	United States	92260
8	Robin K. Dore, MD., Inc.	Tustin	California	United States	92780
9	Southwest Florida Clinical Research Center	Tampa	Florida	United States	33609
10	The Alliance for Multispecialty Resarch (AMR) Whichita East	Wichita	Kansas	United States	67207
11	Shores Rheumatology	Saint Clair Shores	Michigan	United States	48081
12	The Center for Rheumatology	Albany	New York	United States	12203
13	The Center for Rheumatology	Albany	New York	United States	12203
14	Joint and Muscle Research Institute	Charlotte	North Carolina	United States	28204
15	Joint and Muscle Research Institute	Charlotte	North Carolina	United States	28204
16	MetroHealth Medical Systems	Cleveland	Ohio	United States	44109
17	STAT Research, Inc.	Dayton	Ohio	United States	45417
18	Oregon Health and Science University - Knight Cardiovascular Institute	Portland	Oregon	United States	97239
19	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
20	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
21	West Tennessee Research Institute	Jackson	Tennessee	United States	38305
22	Ramesh C Gupta MD	Memphis	Tennessee	United States	38119
23	Ramesh C Gupta MD	Memphis	Tennessee	United States	38119
24	Austin Regional Clinic	Austin	Texas	United States	78731
25	Austin Regional Clinic	Austin	Texas	United States	78731
26	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas	United States	76034
27	Precision Comprehensive Clinical Research Solutions - Fort Worth	Fort Worth	Texas	United States	76107
28	Pioneer Research Solutions	Houston	Texas	United States	77099
29	Southwest Rheumatology Research, LLC	Mesquite	Texas	United States	75150
30	University of Utah	Salt Lake City	Utah	United States	84132
31	University Of Utah	Salt Lake City	Utah	United States	84132
32	University of Alberta	Edmonton	Alberta	Canada	T6G1Z1
33	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
34	CCR Clinical Research Brno	Brno		Czechia	602 00
35	Revmaclinic	Brno		Czechia	61141
36	CCR Ostrava	Ostrava		Czechia	702 00
37	Local Institution - 206	Ostrava		Czechia	702 00
38	Local Institution - 207	Ostrava		Czechia	702 00
39	Vesalion s.r.o.	Ostrava		Czechia	702 00
40	ARTHROMED s.r.o.	Pardubice		Czechia	530 02
41	CCR Czech as	Pardubice		Czechia	530 02
42	Local Institution - 201	Pardubice		Czechia	530 02
43	Affidea Praha s.r.o	Praha 11		Czechia	148 00
44	CCR Prague, s.r.o.	Praha 3		Czechia	13000
45	Revmatologicka Ambulance	Praha 4		Czechia	140 00
46	Thomayerova Hospital	Praha 4		Czechia	140 00
47	Revmatologie	Praha		Czechia	140 00
48	Medical Plus s.r.o.	Uherské Hradište		Czechia	686 01
49	Charite, Campus Benjamin Franklin, Medizinische Klinik III	Bielfeld		Germany	33647
50	Friedrich-Alexander-Universiät Erlangen Nürnberg	Erlangen		Germany	91054
51	Centrum fur innovative Diagnostik und Therapie Rheumatologie und Immunologie (CIRI)	Frankfurt am Main		Germany	60590
52	Local Institution - 900	Herne		Germany	44649
53	Rheumazentrum Ruhrgebiet	Herne		Germany	44649
54	Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk	Bialystok		Poland	15-077
55	Local Institution - 311	Bialystok		Poland	15-077
56	Local Institution - 315	Bialystok		Poland	15-351
57	NZOZ Osteo-Medic sc A. Racewicz J. Supronik	Bialystok		Poland	15-351
58	Local Institution - 305	Bydgoszcz		Poland	85-065
59	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz		Poland	85-065
60	Local Institution - 302	Bydgoszcz		Poland	85-168
61	Szpital Uniwersytecki nr 2 im. J.Biziela	Bydgoszcz		Poland	85-168
62	Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska	Elblag		Poland	82-300
63	Local Institution - 301	Elblag		Poland	82-300
64	Silmedic Sp. z o.o.	Katowice		Poland	40-282
65	Local Institution - 300	Krakow		Poland	30-002
66	Malopolskie Badania Kliniczne Sp. z.o.o Sp k	Krakow		Poland	30-002
67	Centrum Medyczne Plejady	Krakow		Poland	30-363
68	Local Institution - 308	Krakow		Poland	30-363
69	Local Institution - 310	Nowa Sol		Poland	67-100
70	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sol		Poland	67-100
71	Local Institution - 313	Onyksowa 10		Poland	20-582
72	Niepubliczny Zaklad Opieki Zdrowotnej REUMED	Onyksowa 10		Poland	20-582
73	Prywatna Praktyka Lekarska Pawel Hrycaj	Poznan		Poland	61-397
74	Local Institution - 312	Sochaczew		Poland	96-500
75	RCMed Oddzial Sochaczew	Sochaczew		Poland	96-500
76	Local Institution - 306	Torun		Poland	87-100
77	Nasz Lekarz Przychodnie Medyczne	Torun		Poland	87-100
78	Ars Rheumatica-Centrum Reumatologii	Warsaw		Poland	02-691
79	Local Institution - 303	Warsaw		Poland	02-691
80	Centrum Medyczne Oporow	Wroclaw		Poland	52-416
81	Local Institution - 309	Wroclaw		Poland	52-416
82	Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL	Brasov		Romania	500283
83	SC Centrul Medical Sana SRL	Bucuresti		Romania	011025
84	Spitalul Clinic Sfanta Maria	Bucuresti		Romania	011172
85	Spitalul Clinic*	Bucuresti		Romania	011172
86	Spitalul Euroclinic	Bucuresti		Romania	14461
87	Research Medical Complex Vashe Zdorovie	Kazan		Russian Federation	420097
88	City Clinical Hospital No 7 - Kazan	Kazan		Russian Federation	420103
89	Kemerovo Regional Clinical Hospital	Kemerovo		Russian Federation	650066
90	LLC Medical Center Rheuma-Med	Kemerovo		Russian Federation	650070
91	Klinika na Maroseyke, LLC	Moscow		Russian Federation	101000
92	Orenburg Regional Clinical Hospital	Orenburg		Russian Federation	460018
93	Republican Hospital na VA Baranov	Petrozavodsk		Russian Federation	185019
94	State Institution of Healthcare Regional Clinical Hospital	Saratov		Russian Federation	410053
95	Smolensk Regional Clinical Hospital	Smolensk		Russian Federation	214018
96	City Hospital #40	St. Petersburg		Russian Federation	197706
97	State Autonomous Healthcare Institution of Yaroslavl Oblast Clinical Hospital 3	Yaroslavl		Russian Federation	150007
98	Local Institution - 604	A Coruña		Spain	15006
99	University Hospital La Coruna	A Coruña		Spain	15006
100	Hospital Universitario Vall d'Hebron	Barcelona		Spain	08035
101	Hospital Universitario Reina Sofia	Cordoba		Spain	14001
102	Local Institution - 606	Cordoba		Spain	14001
103	Hospital de Merida	Merida		Spain	06800
104	Corporacion Sanitaria Parc Tauli	Sabadell		Spain	8208
105	Local Institution - 601	Sabadell		Spain	8208
106	Hospital Clinico Universitario De Santiago De Compostela	Santiago De Compostela		Spain	15706
107	Local Institution - 602	Santiago De Compostela		Spain	15706
108	Hospital Virgen del Rocio Servicio de Hematologia	Sevilla		Spain	41013
109	Local Institution - 702	Adapazari		Turkey	54100
110	Sakarya University	Adapazari		Turkey	54100
111	Ibn Sina University Hospital (Ankara Üniversitesi İbni Sina Hastanesi)	Altındağ/Ankara		Turkey	06230
112	Hacettepe Universitesi Tip Fakultesi	Ankara		Turkey	06100
113	Local Institution - 700	Ankara		Turkey	06100
114	Local Institution - 701	Edirne		Turkey	22030
115	Trakya University Medical Faculty	Edirne		Turkey	22030
116	Istanbul University Cerrahpasa Medical Faculty Hospital	Istanbul		Turkey	34098
117	Ege Universitesi Medical Faculty	Izmir		Turkey	35100
118	Izmir Katip Celebi Universitesi - Ataturk Education Research Hospital	Karabaglar		Turkey	35360
119	Karadeniz Teknik Universitesi	Trabzon		Turkey	61080
120	Local Institution - 703	Trabzon		Turkey	61080