Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1111-1260-5462 | Registry Identifier | WHO | |
| 2020-005212-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness and safety of 3 dose regimen of CC-93538 in adult participants with moderate to severe Atopic Dermatitis (AD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1: CC-93538 SC QW | Experimental | Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks. |
|
| Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W | Experimental | Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind. |
|
| Dose 3: CC-93538 SC Q2W and Placebo SC weekly | Experimental | Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind. |
|
| Placebo SC QW | Placebo Comparator | Administration of placebo each week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-93538 | Drug | Specified dosages on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change From Baseline in EASI at Week 16 | The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. | From initial EASI measurement to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With an vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥ 2 Points From Baseline at Week 16 | The Validated Investigator Global Assessment (vIGA-AD) is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static evaluation conducted without regard to the score obtained at a previous visit. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose vIGA-AD response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). |
Not provided
Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
Participant must be ≥ 18 years and ≤ 75 years of age and have a body weight of ≥ 40 kg (88.2 lb) at the time of signing the informed consent form (ICF).
Participant has chronic atopic dermatitis (AD) as defined by Hanifin and Rajka that has been present for ≥ 1 year prior to the baseline visit (Day 1).
Participant has moderate to severe, active, and symptomatic AD defined by meeting all of the following criteria on the day of the baseline visit (Day 1):
Participant must have a documented history of inadequate response to treatment with topical medications for at least 4 weeks, unless topical treatments are otherwise medically inadvisable or has required systemic therapy for control of disease.
Participant must be willing to apply a stable dose of topical emollient (eg, over-the-counter moisturizer, non-medicated emollient, etc.) twice daily for ≥ 7 days prior to the Baseline visit and continue application throughout the study.
Participant must commit to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
Participants currently receiving concomitant medications for any reason other than AD, such as inhaled corticosteroids, leukotriene receptor antagonists (eg, montelukast), or mast cell stabilizers (eg, cromolyn sodium) for asthma, must be on a stable regimen, which is defined as not starting a new drug, changing, or stopping dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the treatment duration of the study.
Female participants of childbearing potential must agree to practice a highly effective method of contraception.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Local Institution - 119 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39018038 | Derived | Blauvelt A, Guttman-Yassky E, Lynde C, Khattri S, Schlessinger J, Imafuku S, Tada Y, Morita A, Wiseman M, Kwiek B, Machkova M, Zhang P, Linaberry M, Li J, Zhang S, Franchin G, Charles ED, De Oliveira CHMC, Silverberg JI. Cendakimab in Patients With Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Aug 1;160(8):856-864. doi: 10.1001/jamadermatol.2024.2131. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
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/
See Plan Description
See Plan Description
221 participants Randomized, 220 Participants Treated
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1 | CC-93538 High Dose QW |
| FG001 | Treatment 2 | CC-93538 High Dose Q2W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other | Specified dosages on specified days |
|
| From initial vIGA-AD assessment to week 16 |
| Percentage of EASI-75 Responders at Week 16 | The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-75 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | From initial EASI measurement to week 16 |
| Percentage of EASI-90 Responders at Week 16 | The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-90 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | From initial EASI measurement to week 16 |
| Percent Change in Mean SCORAD Scores From Baseline at Week 16 | The SCORAD is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10). The subject will assess the subjective symptoms (itch and sleepless) part of the assessment. SCORing Atopic Dermatitis Index (SCORAD) score ranges from 0 to 103, higher scores indicate more severe disease. | From initial SCORAD measurement to week 16 |
| Percent Change From Baseline in Pruritus NRS at Week 16 | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). | From initial NRS measurement to week 16 |
| Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16 | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose pruritus NRS response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | From initial NRS assessment to week 16 |
| Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale. | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). | From initial NRS pruritus response up to study day 127 (127 days) |
| Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16 | Body Surface Area involvement will be calculated from the sum of the number of handprints of skin afflicted with atopic dermatitis in a body region. The number of handprints of skin afflicted with atopic dermatitis in a body region can be used to determine the extent (%) to which a body region is involved with AD. When measuring, the handprint unit refers to the size of each individual subject's hand with fingers in a closed position. BSA will be calculated by the Investigator or qualified designee using the 1% handprint rule, in which the area represented by the palm with all 5 digits adducted together is approximately 1% of the subject's BSA. | From initial BSA assessment to week 16 |
| Number of Participants With Treatment Emergent Adverse Events | Treatment emergent adverse events | From first treatment to the end of follow up, approximately 32 weeks |
| Number of Participants With the Presence of Serum Antibodies to CC-93538 | From first treatment to the end of follow up, approximately 32 weeks |
| Serum Trough Concentration at Week 16 | A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of CC-93538 will be summarized with descriptive statistics by treatment and visit. | At week 16 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | From first treatment to the end of follow up, approximately 32 weeks |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Cahaba Dermatology | Birmingham | Alabama | 35244 | United States |
| Local Institution - 114 | Birmingham | Alabama | 35244 | United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913-6440 | United States |
| Local Institution - 129 | Hot Springs | Arkansas | 71913-6440 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Local Institution - 105 | Fountain Valley | California | 92708 | United States |
| George Washington University School of Medicine and Health Sciences | Washington D.C. | District of Columbia | 20037-3201 | United States |
| Local Institution - 128 | Washington D.C. | District of Columbia | 20037-3201 | United States |
| Total Vein and Skin, LLC | Boynton Beach | Florida | 33437 | United States |
| Local Institution - 106 | Delray Beach | Florida | 33484-6500 | United States |
| Palm Beach Dermatology Group | Delray Beach | Florida | 33484-6500 | United States |
| GCP Global Clinical Professionals | St. Petersburg | Florida | 33702 | United States |
| Local Institution - 135 | St. Petersburg | Florida | 33702 | United States |
| ForCare Clinical Research | Tampa | Florida | 33624-2038 | United States |
| Local Institution - 101 | Tampa | Florida | 33624-2038 | United States |
| Local Institution - 103 | West Palm Beach | Florida | 33401-3430 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401-3430 | United States |
| Aeroallergy Research Labs of Savannah | Savannah | Georgia | 31406-2668 | United States |
| Local Institution - 134 | Savannah | Georgia | 31406-2668 | United States |
| Local Institution - 108 | Springfield | Illinois | 62702-5115 | United States |
| Sneeze Wheeze and Itch Associates LLC | Springfield | Illinois | 62702-5115 | United States |
| DS Research | Clarksville | Indiana | 47129-2201 | United States |
| Local Institution - 115 | Clarksville | Indiana | 47129-2201 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Local Institution - 110 | Indianapolis | Indiana | 46256 | United States |
| Local Institution - 107 | West Lafayette | Indiana | 47906-1569 | United States |
| Randall Dermatology | West Lafayette | Indiana | 47906-1569 | United States |
| Local Institution - 138 | Westfield | Indiana | 46074 | United States |
| Randall Dermatology - Westfield Campus | Westfield | Indiana | 46074 | United States |
| Kansas City Dermatology P.A. | Overland Park | Kansas | 66215-2377 | United States |
| Local Institution - 116 | Overland Park | Kansas | 66215-2377 | United States |
| DS Research | Louisville | Kentucky | 40241 | United States |
| Local Institution - 117 | Louisville | Kentucky | 40241 | United States |
| DermAssociates | Silver Spring | Maryland | 20902-5006 | United States |
| Local Institution - 125 | Silver Spring | Maryland | 20902-5006 | United States |
| Local Institution - 133 | Clarkston | Michigan | 48346 | United States |
| Skin Research Clarkston/Clarkston Dermatology | Clarkston | Michigan | 48346 | United States |
| Local Institution - 137 | Omaha | Nebraska | 68144 | United States |
| Skin Specialists PC | Omaha | Nebraska | 68144 | United States |
| JDR Dermatology Research, LLC | Las Vegas | Nevada | 89148 | United States |
| Local Institution - 121 | Las Vegas | Nevada | 89148 | United States |
| Local Institution - 112 | Hackensack | New Jersey | 07601-1974 | United States |
| Skin Laser and Surgery Specialists of New York and New Jersey LLC | Hackensack | New Jersey | 07601-1974 | United States |
| Icahn School of Medicine at Mount Sinai | Great Neck | New York | 11021-5506 | United States |
| Local Institution - 130 | Great Neck | New York | 11021-5506 | United States |
| Local Institution - 126 | New York | New York | 10075 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Central Sooner Research | Norman | Oklahoma | 73069-6301 | United States |
| Local Institution - 111 | Norman | Oklahoma | 73069-6301 | United States |
| Local Institution - 127 | Tulsa | Oklahoma | 74136-8303 | United States |
| Vital Prospects Clinical Research Institute PC - CRN - PPDS | Tulsa | Oklahoma | 74136-8303 | United States |
| Local Institution - 109 | Portland | Oregon | 97223 | United States |
| Oregon Medical Research Center, P.C. | Portland | Oregon | 97223 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Local Institution - 123 | Johnston | Rhode Island | 02919 | United States |
| International Clinical Research | Murfreesboro | Tennessee | 37130 | United States |
| Local Institution - 100 | Murfreesboro | Tennessee | 37130 | United States |
| Clinical Research Partners LLC | Henrico | Virginia | 23233-1487 | United States |
| Local Institution - 104 | Richmond | Virginia | 23233-1436 | United States |
| West End Dermatology Associates | Richmond | Virginia | 23233-1436 | United States |
| Institute for Skin Advancement | Calgary | Alberta | T3A 2N1 | Canada |
| Local Institution - 203 | Calgary | Alberta | T3A 2N1 | Canada |
| Local Institution - 213 | Edmonton | Alberta | T6G 1C3 | Canada |
| Rao Dermatology | Edmonton | Alberta | T6G 1C3 | Canada |
| Dr. Chih-ho Hong Medical Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Local Institution - 207 | Surrey | British Columbia | V3R 6A7 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Local Institution - 200 | Surrey | British Columbia | V3V 0C6 | Canada |
| Local Institution - 205 | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Local Institution - 208 | Markham | Ontario | L3P IX3 | Canada |
| Lynderm Research Inc | Markham | Ontario | L3P IX3 | Canada |
| DermEdge | Mississauga | Ontario | L4Y 4C5 | Canada |
| Local Institution - 211 | Mississauga | Ontario | L4Y 4C5 | Canada |
| Local Institution - 209 | Oakville | Ontario | L6J 7W5 | Canada |
| The Centre for Clinical Trials Inc. | Oakville | Ontario | L6J 7W5 | Canada |
| Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ | Québec | G1V 4X7 | Canada |
| Local Institution - 202 | Québec | G1V 4X7 | Canada |
| Kawashima Dermatology | Ichikawa | 272-0033 | China |
| Local Institution - 503 | Ichikawa | 272-0033 | China |
| Local Institution - 507 | Matsudo | 271-0092 | China |
| Miyata Dermatology Clinic | Matsudo | 271-0092 | China |
| Kozni ambulance Kutna Hora | Kutná Hora | 284 01 | Czechia |
| Local Institution - 407 | Kutná Hora | 284 01 | Czechia |
| Dermamedica | Náchod | 547 01 | Czechia |
| Local Institution - 403 | Náchod | 547 01 | Czechia |
| CCBR Ostrava | Ostrava | 702 00 | Czechia |
| Local Institution - 404 | Ostrava | 702 00 | Czechia |
| Center for Clinical and Basic Research Czech Pardubice | Pardubice | 530 02 | Czechia |
| Local Institution - 405 | Pardubice | 530 02 | Czechia |
| Clintrial | Prague | 100 00 | Czechia |
| Local Institution - 402 | Prague | 100 00 | Czechia |
| CCBR Czech Prague s.r.o. | Prague | 130 00 | Czechia |
| Local Institution - 400 | Prague | 130 00 | Czechia |
| FN Motol | Prague | 15006 | Czechia |
| Local Institution - 401 | Prague | 15006 | Czechia |
| Dermatologicka Ambulance MUDr. Petr Trestik | Svitavy | 568 02 | Czechia |
| Local Institution - 406 | Svitavy | 568 02 | Czechia |
| Local Institution - 514 | Fukuoka | 8140180 | Japan |
| Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers | Fukuoka | 815-8588 | Japan |
| Local Institution - 504 | Fukuoka | 815-8588 | Japan |
| Fukuoka University Hospital | Fukuoka-shi, Fukuoka | 814-0180 | Japan |
| Ichinomiya Municipal Hospital | Ichinomiya | 491-8558 | Japan |
| Local Institution - 506 | Ichinomiya | 491-8558 | Japan |
| Teikyo University Hospital | Itabashi-ku | 173-8606 | Japan |
| Local Institution - 511 | Itabashi-ku | 1738606 | Japan |
| Local Institution - 515 | Kagoshima | 890-0055 | Japan |
| Saruwatari Dermatology Clinic | Kagoshima | 890-0055 | Japan |
| Local Institution - 513 | Kofu | 400-0027 | Japan |
| Yamanashi Prefectual Central Hospital | Kofu | 400-0027 | Japan |
| Local Institution - 505 | Kyoto | 602-8566 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Charme-Clinique | Matsudo | 270-2223 | Japan |
| Local Institution - 510 | Matsudo | 270-2223 | Japan |
| Local Institution - 508 | Nagoya | 467-8602 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| Local Institution - 512 | Obihiro | 080-0013 | Japan |
| Takagi Dermatology | Obihiro | 080-0013 | Japan |
| Local Institution - 517 | Osaka | Osaka | Japan |
| Nakatsu Hifuka Clinic | Osaka | Osaka | Japan |
| Local Institution - 501 | Sapporo | 060-0063 | Japan |
| Medical Corporation Kojinkai Housui Sogo Medical Clinic | Sapporo | 060-0063 | Japan |
| Local Institution - 500 | Sapporo-shi, Hokkaido | 060-0063 | Japan |
| Sapporo Skin Clinic | Sapporo-shi, Hokkaido | 060-0063 | Japan |
| Local Institution - 502 | Shinjuku | 160-0023 | Japan |
| Tokyo Medical University Hospital | Shinjuku | 160-0023 | Japan |
| Local Institution - 509 | Yokohoma City, Kanagawa | 221-0825 | Japan |
| Nomura Dermatology Clinic | Yokohoma City, Kanagawa | 221-0825 | Japan |
| Copernicus Podmiot Leczniczy Sp. z o.o. | Gdansk | 80-803 | Poland |
| Local Institution - 310 | Gdansk | 80-803 | Poland |
| Care Clinic | Katowice | 40-568 | Poland |
| Local Institution - 309 | Katowice | 40-568 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | 40-611 | Poland |
| Local Institution - 306 | Katowice | 40-611 | Poland |
| Local Institution - 303 | Lodz | 90-265 | Poland |
| Specjalistyczne Gabinety Lekarskie DERMED | Lodz | 90-265 | Poland |
| Centrum Medyczne Dermoklinika | Lodz | 90-436 | Poland |
| Local Institution - 311 | Lodz | 90-436 | Poland |
| Local Institution - 312 | Olsztyn | 10-229 | Poland |
| Miejski Szpital Zespolony w Olsztynie | Olsztyn | 10-229 | Poland |
| Klinika Zdybski | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Local Institution - 300 | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Laser Clinic Dermatologia Laserowa Medycyna Estetyczna | Szczecin | 70-332 | Poland |
| Local Institution - 308 | Szczecin | 70-332 | Poland |
| Local Institution - 302 | Szczecin | 71-434 | Poland |
| Twoja Przychodnia Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| High-Med Przychodnia Specjalistyczna | Warsaw | 01-817 | Poland |
| Local Institution - 301 | Warsaw | 01-817 | Poland |
| Klinika Ambroziak Estederm | Warsaw | 02-953 | Poland |
| Local Institution - 307 | Warsaw | 02-953 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie | Wroclaw | 50-367 | Poland |
| Local Institution - 304 | Wroclaw | 50-367 | Poland |
| Centrum Zdrowia WroMedica | Wroclaw | 51-685 | Poland |
| Local Institution - 305 | Wroclaw | 51-685 | Poland |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| FG002 |
| Treatment 3 |
CC-93538 Low Dose Q2W |
| FG003 | Placebo | Placebo |
| COMPLETED | Completed = All randomized participants who recieved at least one dose of study treatment. |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
All Randomized
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1 | CC-93538 High Dose QW |
| BG001 | Treatment 2 | CC-93538 High Dose Q2W |
| BG002 | Treatment 3 | CC-93538 Low Dose Q2W |
| BG003 | Placebo | Placebo |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| modified Intent to treat population (mITT) | All enrolled subjects who received at least 1 dose of CC-93538. Same as the safety population. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percentage Change From Baseline in EASI at Week 16 | The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. | Modified Intent to Treat (mITT) Population | Posted | Mean | Standard Error | Percent Change | From initial EASI measurement to week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders With an vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) and a Reduction ≥ 2 Points From Baseline at Week 16 | The Validated Investigator Global Assessment (vIGA-AD) is a validated 5-point assessment intended to assess the global severities of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static evaluation conducted without regard to the score obtained at a previous visit. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose vIGA-AD response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | Modified Intent to Treat (mITT) Population | Posted | Number | Percentage of Participants | From initial vIGA-AD assessment to week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of EASI-75 Responders at Week 16 | The EASI is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-75 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | modified Intent to Treat (mITT) population | Posted | Number | Percentage of Participants | From initial EASI measurement to week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of EASI-90 Responders at Week 16 | The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better. Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose EASI-90 response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | Modified Intent to Treat (mITT) Population | Posted | Number | Percentage of participants | From initial EASI measurement to week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Mean SCORAD Scores From Baseline at Week 16 | The SCORAD is a validated scoring index for atopic dermatitis, which combines extent (0 to 100), severity (0 to 18), and subjective symptoms (0 to 20) based on pruritus and sleep loss, each scored (0 to 10). The subject will assess the subjective symptoms (itch and sleepless) part of the assessment. SCORing Atopic Dermatitis Index (SCORAD) score ranges from 0 to 103, higher scores indicate more severe disease. | Modified Intent to Treat (mITT) population | Posted | Mean | Standard Error | Percent Change | From initial SCORAD measurement to week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Pruritus NRS at Week 16 | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). | Modified Intent to Treat (mITT) population | Posted | Mean | Standard Error | Percent Change | From initial NRS measurement to week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16 | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). Percentage of responders calculated using Multiple Imputation (MI) approach. For participants discontinued study drug, whose pruritus NRS response at Week 16 are missing or cannot be adequately determined (including missing due to COVID-19) without use of rescue therapy/prohibited medication prior to Week 16, their outcomes will be handled using a MI approach assuming missing at random (MAR). | Modified Intent to Treat (mITT) Population | Posted | Number | Percentage of Participants | From initial NRS assessment to week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale. | Pruritus will be assessed by the subject using the Pruritus NRS, which was developed and validated as a single item, patient reported outcome (PRO) of itch severity. Clinical response is indicated by a ≥ 2 to 4-point change from baseline in Peak Pruritus NRS score. The intensity of pruritus will be assessed based on last 24 hours using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). | Modified Intent to Treat (mITT) Population | Posted | Median | 95% Confidence Interval | Days | From initial NRS pruritus response up to study day 127 (127 days) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16 | Body Surface Area involvement will be calculated from the sum of the number of handprints of skin afflicted with atopic dermatitis in a body region. The number of handprints of skin afflicted with atopic dermatitis in a body region can be used to determine the extent (%) to which a body region is involved with AD. When measuring, the handprint unit refers to the size of each individual subject's hand with fingers in a closed position. BSA will be calculated by the Investigator or qualified designee using the 1% handprint rule, in which the area represented by the palm with all 5 digits adducted together is approximately 1% of the subject's BSA. | Modified Intent to Treat (mITT) Population | Posted | Mean | Standard Error | mean percentage | From initial BSA assessment to week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Treatment emergent adverse events | Modified Intent to Treat (mITT) Population | Posted | Count of Participants | Participants | From first treatment to the end of follow up, approximately 32 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Presence of Serum Antibodies to CC-93538 | Modified Intent to Treat (mITT) Population | Posted | Count of Participants | Participants | From first treatment to the end of follow up, approximately 32 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Trough Concentration at Week 16 | A serum trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered. Serum trough concentrations (Ctrough) of CC-93538 will be summarized with descriptive statistics by treatment and visit. | Pharmacokinetic Population | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Modified Intent to Treat Population (mITT) | Posted | Count of Participants | Participants | From first treatment to the end of follow up, approximately 32 weeks |
|
|
Adverse Events and Serious Adverse Events (From first treatment to end of study): Approximately 32 Weeks All-Cause mortality (From 1st dose of study to end of study): Approximately 33 Weeks
The number at Risk for All-Cause Mortality represents all treated participants.
The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment 1 | CC-93538 High Dose QW | 0 | 54 | 2 | 54 | 34 | 54 |
| EG001 | Treatment 2 | CC-93538 High Dose Q2W | 0 | 55 | 1 | 55 | 35 | 55 |
| EG002 | Treatment 3 | CC-93538 Low Dose Q2W | 0 | 55 | 2 | 55 | 29 | 55 |
| EG003 | Placebo | Placebo | 0 | 56 | 4 | 56 | 34 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 25.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Nov 8, 2023 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625155 | cendakimab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by participant |
|
| Other Reasons |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -13.38 |
| 2-Sided |
| 95 |
| -27.19 |
| 0.43 |
| Superiority |
| ANCOVA | 0.029 | Mean Difference (Final Values) | -16.28 | 2-Sided | 95 | -30.88 | -1.68 | Superiority |
CC-93538 Low Dose Q2W |
| OG003 | Placebo | Placebo |
|
|
|
| OG003 | Placebo | Placebo |
|
|
|
CC-93538 Low Dose Q2W
| OG003 | Placebo | Placebo |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG003 | Placebo | Placebo |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo |
|
|
|
|
|
|
|