A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
- Registration Number
- NCT04800315
- Lead Sponsor
- Celgene
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
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):
- Body Surface Area (BSA) ≥ 10%, and
- EASI score ≥ 16, and
- vIGA-AD ≥ 3, and
- Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
-
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.
- The presence of any of the following will exclude a participant from enrollment: Evidence of an active and/or concurrent inflammatory skin condition (eg, seborrheic dermatitis, psoriasis, acute allergic contact dermatitis, etc.) that would interfere with the Investigator or participant-driven evaluations of AD.
- Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
- Use of topical treatments that could affect the assessment of AD (eg, corticosteroids, calcineurin inhibitors, tars, antibiotic creams, topical antihistamines) within 7 days of the Day 1 visit.
- Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
- Evidence of immunosuppression, participant is receiving, or has received systemic immunosuppressive or immunomodulating drugs (eg, azathioprine, cyclosporine, systemic corticosteroids, interferon gamma (IFN-γ), Janus kinase inhibitors, methotrexate, mycophenolate-mofetil, etc.) within 4 weeks prior to the Baseline visit.
- Treatment with immunomodulatory biologics
- Concurrent treatment with another IP
- Received a live attenuated vaccine within 1 month prior to the first Screening Visit or anticipates the need to be vaccinated with a live attenuated vaccine during the study.
- Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
- Ongoing infection
- A history of idiopathic anaphylaxis or a major immunologic reaction (such as anaphylactic reaction, anaphylactoid reaction, or serum sickness) to an immunoglobulin G (IgG) containing agent. A known hypersensitivity to any ingredient in the investigational product (IP) is also exclusionary.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W Placebo 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 CC-93538 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. Dose 3: CC-93538 SC Q2W and Placebo SC weekly Placebo 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 Administration of placebo each week. Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W CC-93538 Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind. Dose 1: CC-93538 SC QW CC-93538 Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
- Primary Outcome Measures
Name Time Method Mean Percentage Change From Baseline in EASI at Week 16 From initial EASI measurement to 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.
- Secondary Outcome Measures
Name Time Method Percentage of EASI-90 Responders at Week 16 From initial EASI measurement to 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).Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale. From initial NRS pruritus response up to study day 127 (127 days) 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").
Percent Change From Baseline in Pruritus NRS at Week 16 From initial NRS measurement to 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").
Number of Participants With Treatment Emergent Adverse Events From first treatment to the end of follow up, approximately 32 weeks Treatment emergent adverse events
Number of Participants With the Presence of Serum Antibodies to CC-93538 From first treatment to the end of follow up, approximately 32 weeks 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 From initial vIGA-AD assessment to 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).Percent Change in Mean SCORAD Scores From Baseline at Week 16 From initial SCORAD measurement to 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.Percentage of EASI-75 Responders at Week 16 From initial EASI measurement to 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).Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16 From initial NRS assessment to 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).Serum Trough Concentration at Week 16 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.
Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16 From initial BSA assessment to 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.
Number of Participants With Clinically Significant Laboratory Abnormalities From first treatment to the end of follow up, approximately 32 weeks
Trial Locations
- Locations (156)
Local Institution - 125
🇺🇸Silver Spring, Maryland, United States
Dr. Chih-ho Hong Medical Inc.
🇨🇦Surrey, British Columbia, Canada
Local Institution - 213
🇨🇦Edmonton, Alberta, Canada
Kawashima Dermatology
🇨🇳Ichikawa, China
Local Institution - 504
🇯🇵Fukuoka, Japan
Charme-Clinique
🇯🇵Matsudo, Japan
Local Institution - 510
🇯🇵Matsudo, Japan
Local Institution - 501
🇯🇵Sapporo, Japan
Medical Corporation Kojinkai Housui Sogo Medical Clinic
🇯🇵Sapporo, Japan
Copernicus Podmiot Leczniczy Sp. z o.o.
🇵🇱Gdansk, Poland
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Local Institution - 105
🇺🇸Fountain Valley, California, United States
Local Institution - 106
🇺🇸Delray Beach, Florida, United States
Palm Beach Dermatology Group
🇺🇸Delray Beach, Florida, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Aeroallergy Research Labs of Savannah
🇺🇸Savannah, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Local Institution - 110
🇺🇸Indianapolis, Indiana, United States
Local Institution - 130
🇺🇸Great Neck, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸Great Neck, New York, United States
Local Institution - 208
🇨🇦Markham, Ontario, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
DermEdge
🇨🇦Mississauga, Ontario, Canada
Local Institution - 211
🇨🇦Mississauga, Ontario, Canada
Kansas City Dermatology P.A.
🇺🇸Overland Park, Kansas, United States
Local Institution - 205
🇨🇦Winnipeg, Manitoba, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Local Institution - 119
🇺🇸Birmingham, Alabama, United States
Cahaba Dermatology
🇺🇸Birmingham, Alabama, United States
Local Institution - 114
🇺🇸Birmingham, Alabama, United States
Local Institution - 109
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center, P.C.
🇺🇸Portland, Oregon, United States
Local Institution - 137
🇺🇸Omaha, Nebraska, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Local Institution - 200
🇨🇦Surrey, British Columbia, Canada
Local Institution - 112
🇺🇸Hackensack, New Jersey, United States
Skin Specialists PC
🇺🇸Omaha, Nebraska, United States
Skin Laser and Surgery Specialists of New York and New Jersey LLC
🇺🇸Hackensack, New Jersey, United States
George Washington University School of Medicine and Health Sciences
🇺🇸Washington, District of Columbia, United States
Local Institution - 129
🇺🇸Hot Springs, Arkansas, United States
JDR Dermatology Research, LLC
🇺🇸Las Vegas, Nevada, United States
Institute for Skin Advancement
🇨🇦Calgary, Alberta, Canada
Local Institution - 511
🇯🇵Itabashi-ku, Japan
Nakatsu Hifuka Clinic
🇯🇵Osaka, Japan
Local Institution - 128
🇺🇸Washington, District of Columbia, United States
Local Institution - 309
🇵🇱Katowice, Poland
International Clinical Research
🇺🇸Murfreesboro, Tennessee, United States
Local Institution - 310
🇵🇱Gdansk, Poland
Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
🇵🇱Wrocław, Poland
Local Institution - 100
🇺🇸Murfreesboro, Tennessee, United States
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Local Institution - 508
🇯🇵Nagoya, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Japan
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
High-Med Przychodnia Specjalistyczna
🇵🇱Warsaw, Poland
Wojskowy Instytut Medyczny
🇵🇱Warsaw, Poland
Local Institution - 517
🇯🇵Osaka, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku, Japan
Local Institution - 509
🇯🇵Yokohoma City, Kanagawa, Japan
Local Institution - 306
🇵🇱Katowice, Poland
Local Institution - 307
🇵🇱Warsaw, Poland
Local Institution - 207
🇨🇦Surrey, British Columbia, Canada
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Fukuoka, Japan
Local Institution - 512
🇯🇵Obihiro, Japan
Nomura Dermatology Clinic
🇯🇵Yokohoma City, Kanagawa, Japan
Local Institution - 302
🇵🇱Szczecin, Poland
Local Institution - 303
🇵🇱Łódź, Poland
Centrum Medyczne Dermoklinika
🇵🇱Lodz, Poland
Miejski Szpital Zespolony w Olsztynie
🇵🇱Olsztyn, Poland
Local Institution - 308
🇵🇱Szczecin, Poland
Ichinomiya Municipal Hospital
🇯🇵Ichinomiya, Japan
Local Institution - 513
🇯🇵Kofu, Japan
Local Institution - 311
🇵🇱Lodz, Poland
Total Vein and Skin, LLC
🇺🇸Boynton Beach, Florida, United States
GCP Global Clinical Professionals
🇺🇸Saint Petersburg, Florida, United States
Local Institution - 135
🇺🇸Saint Petersburg, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Local Institution - 101
🇺🇸Tampa, Florida, United States
Local Institution - 103
🇺🇸West Palm Beach, Florida, United States
Local Institution - 134
🇺🇸Savannah, Georgia, United States
Local Institution - 108
🇺🇸Springfield, Illinois, United States
Sneeze Wheeze and Itch Associates LLC
🇺🇸Springfield, Illinois, United States
DS Research
🇺🇸Louisville, Kentucky, United States
Local Institution - 115
🇺🇸Clarksville, Indiana, United States
Local Institution - 107
🇺🇸West Lafayette, Indiana, United States
Randall Dermatology
🇺🇸West Lafayette, Indiana, United States
Randall Dermatology - Westfield Campus
🇺🇸Westfield, Indiana, United States
Local Institution - 138
🇺🇸Westfield, Indiana, United States
Local Institution - 117
🇺🇸Louisville, Kentucky, United States
DermAssociates
🇺🇸Silver Spring, Maryland, United States
Local Institution - 133
🇺🇸Clarkston, Michigan, United States
Skin Research Clarkston/Clarkston Dermatology
🇺🇸Clarkston, Michigan, United States
Local Institution - 121
🇺🇸Las Vegas, Nevada, United States
Local Institution - 126
🇺🇸New York, New York, United States
Sadick Research Group
🇺🇸New York, New York, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Local Institution - 111
🇺🇸Norman, Oklahoma, United States
Vital Prospects Clinical Research Institute PC - CRN - PPDS
🇺🇸Tulsa, Oklahoma, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
Clinical Research Partners LLC
🇺🇸Henrico, Virginia, United States
Local Institution - 104
🇺🇸Richmond, Virginia, United States
West End Dermatology Associates
🇺🇸Richmond, Virginia, United States
Local Institution - 203
🇨🇦Calgary, Alberta, Canada
Local Institution - 202
🇨🇦Quebec, Canada
The Centre for Clinical Trials Inc.
🇨🇦Oakville, Ontario, Canada
Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
🇨🇦Quebec, Canada
Local Institution - 209
🇨🇦Oakville, Ontario, Canada
Local Institution - 503
🇨🇳Ichikawa, China
Local Institution - 507
🇨🇳Matsudo, China
Kozni ambulance Kutna Hora
🇨🇿Kutná Hora, Czechia
Miyata Dermatology Clinic
🇨🇳Matsudo, China
Local Institution - 403
🇨🇿Náchod, Czechia
Local Institution - 407
🇨🇿Kutná Hora, Czechia
Local Institution - 404
🇨🇿Ostrava, Czechia
Dermamedica
🇨🇿Náchod, Czechia
CCBR Ostrava
🇨🇿Ostrava, Czechia
Center for Clinical and Basic Research Czech Pardubice
🇨🇿Pardubice, Czechia
Local Institution - 405
🇨🇿Pardubice, Czechia
Local Institution - 401
🇨🇿Praha 5, Czechia
CCBR Czech Prague s.r.o.
🇨🇿Prague, Czechia
Local Institution - 400
🇨🇿Prague, Czechia
FN Motol
🇨🇿Praha 5, Czechia
Clintrial
🇨🇿Praha, Czechia
Local Institution - 402
🇨🇿Praha, Czechia
Dermatologicka Ambulance MUDr. Petr Trestik
🇨🇿Svitavy, Czechia
Local Institution - 406
🇨🇿Svitavy, Czechia
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Local Institution - 514
🇯🇵Fukuoka-Shi, Japan
Local Institution - 506
🇯🇵Ichinomiya, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Japan
Local Institution - 515
🇯🇵Kagoshima, Japan
Saruwatari Dermatology Clinic
🇯🇵Kagoshima, Japan
Yamanashi Prefectual Central Hospital
🇯🇵Kofu, Japan
Local Institution - 505
🇯🇵Kyoto-City, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-City, Japan
Takagi Dermatology
🇯🇵Obihiro, Japan
Sapporo Skin Clinic
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 500
🇯🇵Sapporo-shi, Hokkaido, Japan
Local Institution - 502
🇯🇵Shinjuku, Japan
Care Clinic
🇵🇱Katowice, Poland
Local Institution - 312
🇵🇱Olsztyn, Poland
Local Institution - 300
🇵🇱Ostrowiec Świętokrzyski, Poland
Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
🇵🇱Szczecin, Poland
Klinika Zdybski
🇵🇱Ostrowiec Świętokrzyski, Poland
Local Institution - 301
🇵🇱Warsaw, Poland
Klinika Ambroziak Estederm
🇵🇱Warsaw, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
Centrum Zdrowia WroMedica
🇵🇱Wroclaw, Poland
Local Institution - 305
🇵🇱Wroclaw, Poland
Local Institution - 304
🇵🇱Wrocław, Poland
Specjalistyczne Gabinety Lekarskie DERMED
🇵🇱Łódź, Poland
Local Institution - 116
🇺🇸Overland Park, Kansas, United States
Local Institution - 127
🇺🇸Tulsa, Oklahoma, United States
Rao Dermatology
🇨🇦Edmonton, Alberta, Canada
Local Institution - 123
🇺🇸Johnston, Rhode Island, United States