Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Study Purpose
This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
Recruitment Criteria
|
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 | 12 Years - 75 Years |
| Gender | All |
Inclusion Criteria:
- - Previously participated in prior clinical study CC-93538-EE-001 and either: 1.
- - OR Subject must have participated in Study CC-93538-DDI-001 and completed assessments through the end of treatment visit.
- - Demonstrated ≥ 80% and ≤ 120% overall compliance with required investigational product dosing during the prior studies.
- - Did not permanently discontinue investigational product in the prior studies and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing in the opinion of the Investigator.
- - Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.
Exclusion Criteria:
- - Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
- - Active Helicobacter pylori infection or esophageal varices.
- - Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1.
- - Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1.
- - Received an investigational product, other than that administered in the CC-93538-EE-001 or CC-93538-DDI-001 studies, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID-19).
- - Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
- - Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the participant's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
- - Active parasitic/helminthic infection or a suspected parasitic/helminthic infections or chronic infection (viral hepatitis, tuberculosis, or HIV) - Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
- - Females who are pregnant or lactating.
Trial Details
|
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. |
NCT04991935 |
|
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 3 |
|
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 |
| Principal Investigator Affiliation | Bristol-Myers Squibb |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Canada, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, Switzerland, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Eosinophilic Esophagitis |
| Study Website: | View Trial Website |
Arms
Experimental: Administration of CC-93538
Participants are administered CC-93538 dose subcutaneously once weekly
Interventions
Drug: - CC-93538
CC-93538
Contact a Trial Team
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
Address
Local Institution - 144
Birmingham 4049979, Alabama 4829764, 35211-1320
Status
Address
Local Institution - 082
Phoenix 5308655, Arizona 5551752, 85016
Status
Address
Local Institution - 147
Phoenix 5308655, Arizona 5551752, 85020-4348
Status
Address
Local Institution - 041
Scottsdale 5313457, Arizona 5551752, 85259
Status
Address
Local Institution - 029
Tucson 5318313, Arizona 5551752, 85715
Status
Address
Local Institution - 165
North Little Rock 4124112, Arkansas 4099753, 72117
Status
Address
Local Institution - 075
Lancaster 5364940, California 5332921, 93534
Status
Address
Local Institution - 047
Los Angeles 5368361, California 5332921, 90067
Status
Address
Local Institution - 160
San Diego 5391811, California 5332921, 92103-5639
Status
Address
Local Institution - 068
Aurora 5412347, Colorado 5417618, 80045
Status
Address
Local Institution - 067
Colorado Springs 5417598, Colorado 5417618, 80907
Status
Address
Local Institution - 128
Wheat Ridge 5443948, Colorado 5417618, 80033
Status
Address
Local Institution - 101
Bristol 5282835, Connecticut 4831725, 06010
Status
Address
Local Institution - 076
Farmington 4834272, Connecticut 4831725, 06030
Status
Address
Local Institution - 156
Hamden 4835654, Connecticut 4831725, 06518
Status
Address
Local Institution - 099
Clearwater 4151316, Florida 4155751, 33756-3839
Status
Address
Local Institution - 036
Inverness 4159786, Florida 4155751, 34452
Status
Address
Local Institution - 042
Jacksonville 4160021, Florida 4155751, 32256
Status
Address
Local Institution - 138
Miami 4164138, Florida 4155751, 33144-2035
Status
Address
Local Institution - 146
Orlando 4167147, Florida 4155751, 32806-1041
Status
Address
Local Institution - 169
Pinellas Park 4168630, Florida 4155751, 33781-3228
Status
Address
Local Institution - 168
Plantation 4168782, Florida 4155751, 33324-3345
Status
Address
Local Institution - 037
Port Orange 4169156, Florida 4155751, 32127
Status
Address
Local Institution - 171
Atlanta 4180439, Georgia 4197000, 30328
Status
Address
Local Institution - 054
Atlanta 4180439, Georgia 4197000, 30342
Status
Address
Local Institution - 117
Macon 4207400, Georgia 4197000, 31201
Status
Address
Local Institution - 024
Idaho Falls 5596475, Idaho 5596512, 83404
Status
Address
Local Institution - 039
Chicago 4887398, Illinois 4896861, 60611
Status
Address
Local Institution - 167
Gurnee 4894861, Illinois 4896861, 60031-5711
Status
Address
Local Institution - 127
Clive 4852065, Iowa 4862182, 50325
Status
Address
Local Institution - 094
Iowa City 4862034, Iowa 4862182, 52242
Status
Address
Local Institution - 035
Kansas City 4273837, Kansas 4273857, 66160
Status
Address
Local Institution - 046
Florence 4291945, Kentucky 6254925, 41042
Status
Address
Local Institution - 003
Baton Rouge 4315588, Louisiana 4331987, 70809
Status
Address
Local Institution - 020
Metairie 4333177, Louisiana 4331987, 70006
Status
Address
Local Institution - 044
Metairie 4333177, Louisiana 4331987, 70006
Status
Address
Local Institution - 164
Columbia 4352053, Maryland 4361885, 21045
Status
Address
Local Institution - 070
Glen Burnie 4356188, Maryland 4361885, 21061
Status
Address
Local Institution - 012
Hagerstown 4357141, Maryland 4361885, 21742
Status
Address
Local Institution - 053
Boston 4930956, Massachusetts 6254926, 02111
Status
Address
Local Institution - 083
South Dartmouth 4951356, Massachusetts 6254926, 02747
Status
Address
Local Institution - 009
Worcester 4956184, Massachusetts 6254926, 01655
Status
Address
Local Institution - 014
Wyoming 5015618, Michigan 5001836, 49519
Status
Address
Local Institution - 115
Plymouth 5041926, Minnesota 5037779, 55446
Status
Address
Local Institution - 049
Rochester 5043473, Minnesota 5037779, 55905
Status
Address
Local Institution - 007
Kansas City 4393217, Missouri 4398678, 64111
Status
Address
Local Institution - 032
St Louis 4407066, Missouri 4398678, 63110
Status
Address
Local Institution - 038
Omaha 5074472, Nebraska 5073708, 68198
Status
Address
Local Institution - 015
Lebanon 5088597, New Hampshire 5090174, 03756
Status
Address
Local Institution - 139
Albuquerque 5454711, New Mexico 5481136, 87106-4725
Status
Address
Local Institution - 028
Great Neck 5119218, New York 5128638, 11023
Status
Address
Local Institution - 051
New York 5128581, New York 5128638, 10016-4744
Status
Address
Local Institution - 116
Syracuse 5140405, New York 5128638, 13210-2306
Status
Address
Local Institution - 142
Syracuse 5140405, New York 5128638, 13210
Status
Address
Local Institution - 016
Chapel Hill 4460162, North Carolina 4482348, 27599
Status
Address
Local Institution - 106
Durham 4464368, North Carolina 4482348, 27705
Status
Address
Local Institution - 131
Greensboro 4469146, North Carolina 4482348, 27405
Status
Address
Local Institution - 130
Beavercreek 4506008, Ohio 5165418, 45440-3237
Status
Address
Local Institution - 006
Cincinnati 4508722, Ohio 5165418, 45219
Status
Address
Local Institution - 001
Cincinnati 4508722, Ohio 5165418, 45229
Status
Address
Local Institution - 052
Cincinnati 4508722, Ohio 5165418, 45267
Status
Address
Local Institution - 059
Columbus 4509177, Ohio 5165418, 43235
Status
Address
Local Institution - 166
Oklahoma City 4544349, Oklahoma 4544379, 73112-5550
Status
Address
Local Institution - 120
Hershey 5193342, Pennsylvania 6254927, 17033
Status
Address
Local Institution - 025
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Address
Local Institution - 155
Pottsville 5207080, Pennsylvania 6254927, 17901-3636
Status
Address
Local Institution - 143
Anderson 4569298, South Carolina 4597040, 29621-2062
Status
Address
Local Institution - 057
Greenville 4580543, South Carolina 4597040, 29615
Status
Address
Local Institution - 114
Chattanooga 4612862, Tennessee 4662168, 37421
Status
Address
Local Institution - 095
Nashville 4644585, Tennessee 4662168, 37212
Status
Address
Local Institution - 105
Cedar Park 4679867, Texas 4736286, 78613
Status
Address
Local Institution - 148
Dallas 4684888, Texas 4736286, 75234-7858
Status
Address
Local Institution - 112
Houston 4699066, Texas 4736286, 77079-2211
Status
Address
Local Institution - 008
San Antonio 4726206, Texas 4736286, 78229
Status
Address
Local Institution - 077
Southlake 4733313, Texas 4736286, 76092
Status
Address
Local Institution - 104
Tyler 4738214, Texas 4736286, 75701
Status
Address
Local Institution - 125
Ogden 5779206, Utah 5549030, 84403-3323
Status
Address
Local Institution - 013
Lynchburg 4771075, Virginia 6254928, 24502
Status
Address
Local Institution - 064
Richmond 4781708, Virginia 6254928, 23249
Status
Address
Local Institution - 137
Spokane 5811696, Washington 5815135, 99218
Status
Address
Local Institution - 023
Vancouver 5814616, Washington 5815135, 98664
International Sites
Status
Address
Local Institution - 695
Mar del Plata 3430863, , B7600DHK
Status
Address
Local Institution - 696
Quilmes 3429652, , B1878DVB
Status
Address
Local Institution - 548
Concord 2170852, New South Wales 2155400, 2139
Status
Address
Local Institution - 554
Liverpool 2159851, New South Wales 2155400, 2170
Status
Address
Local Institution - 540
Westmead 2143973, New South Wales 2155400, 2145
Status
Address
Local Institution - 546
Maroorchydore, Queensland 2152274, 4558
Status
Address
Local Institution - 550
South Brisbane 2207259, Queensland 2152274, 4101
Status
Address
Local Institution - 542
Woolloongabba 6943568, Queensland 2152274, 4102
Status
Address
Local Institution - 552
Adelaide 2078025, South Australia 2061327, 5000
Status
Address
Local Institution - 545
Elizabeth Vale 9973185, South Australia 2061327, 05112
Status
Address
Local Institution - 553
Clayton 2171400, Victoria 2145234, 3168
Status
Address
Local Institution - 543
Footscray 2166370, Victoria 2145234, 3011
Status
Address
Local Institution - 539
Melbourne 2158177, Victoria 2145234, 3004
Status
Address
Local Institution - 549
Murdoch 8349091, Western Australia 2058645, 6150
Status
Address
Local Institution - 538
Fitzroy 2166584, , 3065
Status
Address
Local Institution - 547
Western Australia, , 6056
Status
Address
Local Institution - 437
Burgenland, , 7000
Status
Address
Local Institution - 434
Graz 2778067, , 8036
Status
Address
Local Institution - 436
Linz 2772400, , 4010
Status
Address
Local Institution - 515
Brussels 2800866, , 1090
Status
Address
Local Institution - 516
Kortrijk 2794055, , 8500
Status
Address
Local Institution - 514
Leuven 2792482, , 3000
Status
Address
Local Institution - 512
West-Vlaanderen, , 8310
Status
Address
Local Institution - 201
Calgary 5913490, Alberta 5883102, T2N 2T9
Status
Address
Local Institution - 208
Edmonton 5946768, Alberta 5883102, T5R 1W2
Status
Address
Local Institution - 205
Edmonton 5946768, Alberta 5883102, T6K 4B2
Status
Address
Local Institution - 203
Vancouver 6173331, British Columbia 5909050, V6Z 2K5
Status
Address
Local Institution - 206
Victoria 6174041, British Columbia 5909050, V8V3M9
Status
Address
Local Institution - 207
Ottawa 6094817, Ontario 6093943, K1H 1E4
Status
Address
Local Institution - 200
Vaughan 6173577, Ontario 6093943, L4L 4Y7
Status
Address
Local Institution - 330
Bayern 2951841, , 82418
Status
Address
Local Institution - 332
Brandenburg 2945358, , 14770
Status
Address
Local Institution - 339
Frankfurt am Main 2925533, , 60313
Status
Address
Local Institution - 338
Leipzig 2879139, , 04129
Status
Address
Local Institution - 337
München 2867711, , 81675
Status
Address
Local Institution - 278
Tel Aviv 293397, Tel Aviv 293396, 64239
Status
Address
Local Institution - 281
Haifa 294801, , 3109601
Status
Address
Local Institution - 283
Holon 294751, , 5822012
Status
Address
Local Institution - 280
Jerusalem 281184, , 91031
Status
Address
Local Institution - 282
Jerusalem 281184, , 91120
Status
Address
Local Institution - 279
Ẕerifin 293084, , 70300
Status
Address
Local Institution - 257
Genova 8969657, , 16132
Status
Address
Local Institution - 254
Milan 6951411, , 20122
Status
Address
Local Institution - 255
Padua 3171728, , 35128
Status
Address
Local Institution - 252
Pisa 3170647, , 56100
Status
Address
Local Institution - 253
Rome 3169070, , 00161
Status
Address
Local Institution - 600
Nishinomiya 1855207, Hyōgo 1862047, 663-8501
Status
Address
Local Institution - 595
Bunkyo-ku, Tokyo 1850144, 113-8603
Status
Address
Local Institution - 599
Setagaya-ku, Tokyo 1850144, 157-8535
Status
Address
Local Institution - 593
Akita 2113126, , 010-8543
Status
Address
Local Institution - 606
Isehara City, Kanagawa, , 259-1193
Status
Address
Local Institution - 597
Kobe 1859171, , 650-0017
Status
Address
Local Institution - 598
Maebashi 1857843, , 371-8511
Status
Address
Local Institution - 607
Nagoya 1856057, , 467-8602
Status
Address
Local Institution - 603
Okayama 1854383, , 700-8505
Status
Address
Local Institution - 602
Shinjuku-Ku, , 162-8655
Status
Address
Local Institution - 605
Tokyo 1850147, , 108-8329
Status
Address
Local Institution - 590
Yamagata 2110556, , 990-9585
Status
Address
Local Institution - 385
Bydgoszcz 3102014, , 85-079
Status
Address
Local Institution - 389
Częstochowa 3100946, , 42-202
Status
Address
Local Institution - 390
Gdansk 3099434, , 80-382
Status
Address
Local Institution - 388
Katowice 3096472, , 40-040
Status
Address
Local Institution - 392
Lódz, , 90-127
Status
Address
Local Institution - 387
Warsaw 756135, , 00-189
Status
Address
Local Institution - 393
Warsaw 756135, , 01-192
Status
Address
Local Institution - 383
Warsaw 756135, , 04-501
Status
Address
Local Institution - 391
Wroclaw 3081368, , 50-088
Status
Address
Local Institution - 384
Wroclaw 3081368, , 51-162
Status
Address
Local Institution - 307
Lisbon 2267057, , 1169-045
Status
Address
Local Institution - 305
Lisbon 2267057, , 1649-035
Status
Address
Local Institution - 306
Porto 2735943, , 4099-001
Status
Address
Local Institution - 308
Porto 2735943, , 4200-319
Status
Address
Local Institution - 408
Barcelona 3128760, , 08036
Status
Address
Local Institution - 410
Córdoba 2519240, , 14001
Status
Address
Local Institution - 409
Madrid 3117735, , 28006
Status
Address
Local Institution - 413
Madrid 3117735, , 28046
Status
Address
Local Institution - 411
Marbella 2514169, , 29603
Status
Address
Local Institution - 412
Seville 2510911, , 41013
Status
Address
Local Institution - 357
Lausanne 2659994, , 1011
Status
Address
Local Institution - 228
Belfast Northern Ireland, , BT9 7AB
Status
Address
Local Institution - 231
Birmingham 2655603, , B15 2SQ
Status
Address
Local Institution - 234
Cardiff 2653822, , CF15 9SS
Status
Address
Local Institution - 235
Chorley 2653086, , PR7 7NA
Status
Address
Local Institution - 233
Hexam, , NE46 1QJ
Status
Address
Local Institution - 236
Liverpool 2644210, , L22 0LG
Status
Address
Local Institution - 237
Manchester 2643123, , M15 6SX
