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, Alabama, 35211-1320
Status
Address
Local Institution - 082
Phoenix, Arizona, 85016
Status
Address
Local Institution - 147
Phoenix, Arizona, 85020-4348
Status
Address
Local Institution - 041
Scottsdale, Arizona, 85259
Status
Address
Local Institution - 029
Tucson, Arizona, 85715
Status
Address
Local Institution - 165
North Little Rock, Arkansas, 72117
Status
Address
Local Institution - 075
Lancaster, California, 93534
Status
Address
Local Institution - 047
Los Angeles, California, 90067
Status
Address
Local Institution - 160
San Diego, California, 92103-5639
Status
Address
Local Institution - 068
Aurora, Colorado, 80045
Status
Address
Local Institution - 067
Colorado Springs, Colorado, 80907
Status
Address
Local Institution - 128
Wheat Ridge, Colorado, 80033
Status
Address
Local Institution - 101
Bristol, Connecticut, 06010
Status
Address
Local Institution - 076
Farmington, Connecticut, 06030
Status
Address
Local Institution - 156
Hamden, Connecticut, 06518
Status
Address
Local Institution - 099
Clearwater, Florida, 33756-3839
Status
Address
Local Institution - 036
Inverness, Florida, 34452
Status
Address
Local Institution - 042
Jacksonville, Florida, 32256
Status
Address
Local Institution - 138
Miami, Florida, 33144-2035
Status
Address
Local Institution - 146
Orlando, Florida, 32806-1041
Status
Address
Local Institution - 169
Pinellas Park, Florida, 33781-3228
Status
Address
Local Institution - 168
Plantation, Florida, 33324-3345
Status
Address
Local Institution - 037
Port Orange, Florida, 32127
Status
Address
Local Institution - 171
Atlanta, Georgia, 30328
Status
Address
Local Institution - 054
Atlanta, Georgia, 30342
Status
Address
Local Institution - 117
Macon, Georgia, 31201
Status
Address
Local Institution - 024
Idaho Falls, Idaho, 83404
Status
Address
Local Institution - 039
Chicago, Illinois, 60611
Status
Address
Local Institution - 167
Gurnee, Illinois, 60031-5711
Status
Address
Local Institution - 127
Clive, Iowa, 50325
Status
Address
Local Institution - 094
Iowa City, Iowa, 52242
Status
Address
Local Institution - 035
Kansas City, Kansas, 66160
Status
Address
Local Institution - 046
Florence, Kentucky, 41042
Status
Address
Local Institution - 003
Baton Rouge, Louisiana, 70809
Status
Address
Local Institution - 020
Metairie, Louisiana, 70006
Status
Address
Local Institution - 044
Metairie, Louisiana, 70006
Status
Address
Local Institution - 164
Columbia, Maryland, 21045
Status
Address
Local Institution - 070
Glen Burnie, Maryland, 21061
Status
Address
Local Institution - 012
Hagerstown, Maryland, 21742
Status
Address
Local Institution - 053
Boston, Massachusetts, 02111
Status
Address
Local Institution - 083
South Dartmouth, Massachusetts, 02747
Status
Address
Local Institution - 009
Worcester, Massachusetts, 01655
Status
Address
Local Institution - 014
Wyoming, Michigan, 49519
Status
Address
Local Institution - 115
Plymouth, Minnesota, 55446
Status
Address
Local Institution - 049
Rochester, Minnesota, 55905
Status
Address
Local Institution - 007
Kansas City, Missouri, 64111
Status
Address
Local Institution - 032
Saint Louis, Missouri, 63110
Status
Address
Local Institution - 038
Omaha, Nebraska, 68198
Status
Address
Local Institution - 015
Lebanon, New Hampshire, 03756
Status
Address
Local Institution - 139
Albuquerque, New Mexico, 87106-4725
Status
Address
Local Institution - 028
Great Neck, New York, 11023
Status
Address
Local Institution - 051
New York, New York, 10016-4744
Status
Address
Local Institution - 116
Syracuse, New York, 13210-2306
Status
Address
Local Institution - 142
Syracuse, New York, 13210
Status
Address
Local Institution - 016
Chapel Hill, North Carolina, 27599
Status
Address
Local Institution - 106
Durham, North Carolina, 27705
Status
Address
Local Institution - 131
Greensboro, North Carolina, 27405
Status
Address
Local Institution - 130
Beavercreek, Ohio, 45440-3237
Status
Address
Local Institution - 006
Cincinnati, Ohio, 45219
Status
Address
Local Institution - 001
Cincinnati, Ohio, 45229
Status
Address
Local Institution - 052
Cincinnati, Ohio, 45267
Status
Address
Local Institution - 059
Columbus, Ohio, 43235
Status
Address
Local Institution - 166
Oklahoma City, Oklahoma, 73112-5550
Status
Address
Local Institution - 120
Hershey, Pennsylvania, 17033
Status
Address
Local Institution - 025
Philadelphia, Pennsylvania, 19104
Status
Address
Local Institution - 155
Pottsville, Pennsylvania, 17901-3636
Status
Address
Local Institution - 143
Anderson, South Carolina, 29621-2062
Status
Address
Local Institution - 057
Greenville, South Carolina, 29615
Status
Address
Local Institution - 114
Chattanooga, Tennessee, 37421
Status
Address
Local Institution - 095
Nashville, Tennessee, 37212
Status
Address
Local Institution - 105
Cedar Park, Texas, 78613
Status
Address
Local Institution - 148
Dallas, Texas, 75234-7858
Status
Address
Local Institution - 112
Houston, Texas, 77079-2211
Status
Address
Local Institution - 008
San Antonio, Texas, 78229
Status
Address
Local Institution - 077
Southlake, Texas, 76092
Status
Address
Local Institution - 104
Tyler, Texas, 75701
Status
Address
Local Institution - 125
Ogden, Utah, 84403-3323
Status
Address
Local Institution - 013
Lynchburg, Virginia, 24502
Status
Address
Local Institution - 064
Richmond, Virginia, 23249
Status
Address
Local Institution - 137
Spokane, Washington, 99218
Status
Address
Local Institution - 023
Vancouver, Washington, 98664
International Sites
Status
Address
Local Institution - 695
Mar Del Plata, , B7600DHK
Status
Address
Local Institution - 696
Quilmes, , B1878DVB
Status
Address
Local Institution - 548
Concord, New South Wales, 2139
Status
Address
Local Institution - 554
Liverpool, New South Wales, 2170
Status
Address
Local Institution - 540
Westmead, New South Wales, 2145
Status
Address
Local Institution - 546
Maroorchydore, Queensland, 4558
Status
Address
Local Institution - 550
South Brisbane, Queensland, 4101
Status
Address
Local Institution - 542
Woolloongabba, Queensland, 4102
Status
Address
Local Institution - 552
Adelaide, South Australia, 5000
Status
Address
Local Institution - 545
Elizabeth Vale, South Australia, 05112
Status
Address
Local Institution - 553
Clayton, Victoria, 3168
Status
Address
Local Institution - 543
Footscray, Victoria, 3011
Status
Address
Local Institution - 539
Melbourne, Victoria, 3004
Status
Address
Local Institution - 549
Murdoch, Western Australia, 6150
Status
Address
Local Institution - 538
Fitzroy, , 3065
Status
Address
Local Institution - 547
Western Australia, , 6056
Status
Address
Local Institution - 437
Burgenland, , 7000
Status
Address
Local Institution - 434
Graz, , 8036
Status
Address
Local Institution - 436
Linz, , 4010
Status
Address
Local Institution - 515
Brussels, , 1090
Status
Address
Local Institution - 516
Kortrijk, , 8500
Status
Address
Local Institution - 514
Leuven, , 3000
Status
Address
Local Institution - 512
West-Vlaanderen, , 8310
Status
Address
Local Institution - 201
Calgary, Alberta, T2N 2T9
Status
Address
Local Institution - 208
Edmonton, Alberta, T5R 1W2
Status
Address
Local Institution - 205
Edmonton, Alberta, T6K 4B2
Status
Address
Local Institution - 203
Vancouver, British Columbia, V6Z 2K5
Status
Address
Local Institution - 206
Victoria, British Columbia, V8V3M9
Status
Address
Local Institution - 207
Ottawa, Ontario, K1H 1E4
Status
Address
Local Institution - 200
Vaughan, Ontario, L4L 4Y7
Status
Address
Local Institution - 330
Bayern, , 82418
Status
Address
Local Institution - 332
Brandenburg an der Havel, , 14770
Status
Address
Local Institution - 339
Frankfurt am Main, , 60313
Status
Address
Local Institution - 338
Leipzig, , 04129
Status
Address
Local Institution - 337
Munchen, , 81675
Status
Address
Local Institution - 278
Tel-Aviv, Tel Aviv, 64239
Status
Address
Local Institution - 281
Haifa, , 3109601
Status
Address
Local Institution - 283
Holon, , 5822012
Status
Address
Local Institution - 280
Jerusalem, , 91031
Status
Address
Local Institution - 282
Jerusalem, , 91120
Status
Address
Local Institution - 279
Zerifin, , 70300
Status
Address
Local Institution - 257
Genova, , 16132
Status
Address
Local Institution - 254
Milano, , 20122
Status
Address
Local Institution - 255
Padova, , 35128
Status
Address
Local Institution - 252
Pisa, , 56100
Status
Address
Local Institution - 253
Rome, , 00161
Status
Address
Local Institution - 600
Nishinomiya, Hyogo, 663-8501
Status
Address
Local Institution - 595
Bunkyo-ku, Tokyo, 113-8603
Status
Address
Local Institution - 599
Setagaya-ku, Tokyo, 157-8535
Status
Address
Local Institution - 593
Akita-shi, , 010-8543
Status
Address
Local Institution - 606
Isehara City, Kanagawa, , 259-1193
Status
Address
Local Institution - 597
Kobe, , 650-0017
Status
Address
Local Institution - 598
Maebashi, , 371-8511
Status
Address
Local Institution - 607
Nagoya, , 467-8602
Status
Address
Local Institution - 603
Okayama-Shi, , 700-8505
Status
Address
Local Institution - 602
Shinjuku-Ku, , 162-8655
Status
Address
Local Institution - 605
Tokyo, , 108-8329
Status
Address
Local Institution - 590
Yamagata, , 990-9585
Status
Address
Local Institution - 385
Bydgoszcz, , 85-079
Status
Address
Local Institution - 389
Częstochowa, , 42-202
Status
Address
Local Institution - 390
Gdansk, , 80-382
Status
Address
Local Institution - 388
Katowice, , 40-040
Status
Address
Local Institution - 392
Lódz, , 90-127
Status
Address
Local Institution - 383
Warsaw, , 04-501
Status
Address
Local Institution - 387
Warszawa, , 00-189
Status
Address
Local Institution - 393
Warszawa, , 01-192
Status
Address
Local Institution - 391
Wroclaw, , 50-088
Status
Address
Local Institution - 384
Wroclaw, , 51-162
Status
Address
Local Institution - 307
Lisboa, , 1169-045
Status
Address
Local Institution - 305
Lisboa, , 1649-035
Status
Address
Local Institution - 306
Porto, , 4099-001
Status
Address
Local Institution - 308
Porto, , 4200-319
Status
Address
Local Institution - 408
Barcelona, , 08036
Status
Address
Local Institution - 410
Cordoba, , 14001
Status
Address
Local Institution - 409
Madrid, , 28006
Status
Address
Local Institution - 413
Madrid, , 28046
Status
Address
Local Institution - 411
Marbella, , 29603
Status
Address
Local Institution - 412
Sevilla, , 41013
Status
Address
Local Institution - 357
Lausanne, , 1011
Status
Address
Local Institution - 228
Belfast Northern Ireland, , BT9 7AB
Status
Address
Local Institution - 231
Birmingham, , B15 2SQ
Status
Address
Local Institution - 234
Cardiff, , CF15 9SS
Status
Address
Local Institution - 235
Chorley, , PR7 7NA
Status
Address
Local Institution - 233
Hexam, , NE46 1QJ
Status
Address
Local Institution - 236
Liverpool, , L22 0LG
Status
Address
Local Institution - 237
Manchester, , M15 6SX
