Clinical trial NCT04800315: A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Eczema
Keywords: Atopic Dermatitis
Cendakimab
CC-93538
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

Participants must satisfy the following criteria to be enrolled in the study:

1. 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).
2. 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).
3. 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):

   1. Body Surface Area (BSA) ≥ 10%, and
   2. EASI score ≥ 16, and
   3. vIGA-AD ≥ 3, and
   4. Pruritus Numeric Rating Scale (NRS) severity score ≥ 4.
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.
5. 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.
6. 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.
7. 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.
8. Female participants of childbearing potential must agree to practice a highly effective method of contraception.

Exclusion Criteria:

1. 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.
2. Evidence of acute AD flare between the Screening and Baseline/ Randomization (eg, doubling of the EASI score between Screening and Baseline).
3. 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.
4. Received phototherapy narrowband UVB (NB-UVB) or broad band phototherapy within 4 weeks prior to the Baseline visit.
5. 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.
6. Treatment with immunomodulatory biologics
7. Concurrent treatment with another IP
8. 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.
9. Active parasitic/helminthic infection or a suspected parasitic/helminthic infection.
10. Ongoing infection
11. 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.

Primary outcomes:
measure: Mean Percentage Change From Baseline in EASI at Week 16
timeFrame: From initial EASI measurement to week 16
Secondary outcomes:
measure: 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
timeFrame: From initial vIGA-AD assessment to week 16
measure: Percentage of EASI-75 Responders at Week 16
timeFrame: From initial EASI measurement to week 16
measure: Percentage of EASI-90 Responders at Week 16
timeFrame: From initial EASI measurement to week 16
measure: Percent Change in Mean SCORAD Scores From Baseline at Week 16
timeFrame: From initial SCORAD measurement to week 16
measure: Percent Change From Baseline in Pruritus NRS at Week 16
timeFrame: From initial NRS measurement to week 16
measure: Percentage of Participants With a Response and Pruritus NRS Change of ≥ 4 Points From Baseline at Week 16
timeFrame: From initial NRS assessment to week 16
measure: Time to Achieve at Least 4 Points of Improvement in the Severity of Pruritus NRS Scale.
timeFrame: From initial NRS pruritus response up to study day 127 (127 days)
measure: Adjust Mean Percentage Change in BSA in Atopic Dermatitis From Baseline at Week 16
timeFrame: From initial BSA assessment to week 16
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From first treatment to the end of follow up, approximately 32 weeks
measure: Number of Participants With the Presence of Serum Antibodies to CC-93538
timeFrame: From first treatment to the end of follow up, approximately 32 weeks
measure: Serum Trough Concentration at Week 16
timeFrame: At week 16
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: From first treatment to the end of follow up, approximately 32 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Birmingham
country: United States
facility: Local Institution - 119
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Birmingham
country: United States
facility: Local Institution - 114
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Hot Springs
country: United States
facility: Local Institution - 129
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fountain Valley
country: United States
facility: Local Institution - 105
state: California
city: Washington
country: United States
facility: George Washington University School of Medicine and Health Sciences
state: District of Columbia
city: Washington
country: United States
facility: Local Institution - 128
state: District of Columbia
city: Boynton Beach
country: United States
facility: Total Vein and Skin, LLC
state: Florida
city: Delray Beach
country: United States
facility: Local Institution - 106
state: Florida
city: Delray Beach
country: United States
facility: Palm Beach Dermatology Group
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Global Clinical Professionals
state: Florida
city: Saint Petersburg
country: United States
facility: Local Institution - 135
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Tampa
country: United States
facility: Local Institution - 101
state: Florida
city: West Palm Beach
country: United States
facility: Local Institution - 103
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Labs of Savannah
state: Georgia
city: Savannah
country: United States
facility: Local Institution - 134
state: Georgia
city: Springfield
country: United States
facility: Local Institution - 108
state: Illinois
city: Springfield
country: United States
facility: Sneeze Wheeze and Itch Associates LLC
state: Illinois
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Clarksville
country: United States
facility: Local Institution - 115
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 110
state: Indiana
city: West Lafayette
country: United States
facility: Local Institution - 107
state: Indiana
city: West Lafayette
country: United States
facility: Randall Dermatology
state: Indiana
city: Westfield
country: United States
facility: Local Institution - 138
state: Indiana
city: Westfield
country: United States
facility: Randall Dermatology - Westfield Campus
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology P.A.
state: Kansas
city: Overland Park
country: United States
facility: Local Institution - 116
state: Kansas
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 117
state: Kentucky
city: Silver Spring
country: United States
facility: DermAssociates
state: Maryland
city: Silver Spring
country: United States
facility: Local Institution - 125
state: Maryland
city: Clarkston
country: United States
facility: Local Institution - 133
state: Michigan
city: Clarkston
country: United States
facility: Skin Research Clarkston/Clarkston Dermatology
state: Michigan
city: Omaha
country: United States
facility: Local Institution - 137
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Las Vegas
country: United States
facility: JDR Dermatology Research, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Local Institution - 121
state: Nevada
city: Hackensack
country: United States
facility: Local Institution - 112
state: New Jersey
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of New York and New Jersey LLC
state: New Jersey
city: Great Neck
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Great Neck
country: United States
facility: Local Institution - 130
state: New York
city: New York
country: United States
facility: Local Institution - 126
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Norman
country: United States
facility: Local Institution - 111
state: Oklahoma
city: Tulsa
country: United States
facility: Local Institution - 127
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC - CRN - PPDS
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 109
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center, P.C.
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Johnston
country: United States
facility: Local Institution - 123
state: Rhode Island
city: Murfreesboro
country: United States
facility: International Clinical Research
state: Tennessee
city: Murfreesboro
country: United States
facility: Local Institution - 100
state: Tennessee
city: Henrico
country: United States
facility: Clinical Research Partners LLC
state: Virginia
city: Richmond
country: United States
facility: Local Institution - 104
state: Virginia
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Calgary
country: Canada
facility: Local Institution - 203
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 213
state: Alberta
city: Edmonton
country: Canada
facility: Rao Dermatology
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Local Institution - 207
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Surrey
country: Canada
facility: Local Institution - 200
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution - 205
state: Manitoba
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Markham
country: Canada
facility: Local Institution - 208
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge
state: Ontario
city: Mississauga
country: Canada
facility: Local Institution - 211
state: Ontario
city: Oakville
country: Canada
facility: Local Institution - 209
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials Inc.
state: Ontario
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ
city: Quebec
country: Canada
facility: Local Institution - 202
city: Ichikawa
country: China
facility: Kawashima Dermatology
city: Ichikawa
country: China
facility: Local Institution - 503
city: Matsudo
country: China
facility: Local Institution - 507
city: Matsudo
country: China
facility: Miyata Dermatology Clinic
city: Kutná Hora
country: Czechia
facility: Kozni ambulance Kutna Hora
city: Kutná Hora
country: Czechia
facility: Local Institution - 407
city: Náchod
country: Czechia
facility: Dermamedica
city: Náchod
country: Czechia
facility: Local Institution - 403
city: Ostrava
country: Czechia
facility: CCBR Ostrava
city: Ostrava
country: Czechia
facility: Local Institution - 404
city: Pardubice
country: Czechia
facility: Center for Clinical and Basic Research Czech Pardubice
city: Pardubice
country: Czechia
facility: Local Institution - 405
city: Prague
country: Czechia
facility: CCBR Czech Prague s.r.o.
city: Prague
country: Czechia
facility: Local Institution - 400
city: Praha 5
country: Czechia
facility: FN Motol
city: Praha 5
country: Czechia
facility: Local Institution - 401
city: Praha
country: Czechia
facility: Clintrial
city: Praha
country: Czechia
facility: Local Institution - 402
city: Svitavy
country: Czechia
facility: Dermatologicka Ambulance MUDr. Petr Trestik
city: Svitavy
country: Czechia
facility: Local Institution - 406
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka-Shi
country: Japan
facility: Local Institution - 514
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
city: Fukuoka
country: Japan
facility: Local Institution - 504
city: Ichinomiya
country: Japan
facility: Ichinomiya Municipal Hospital
city: Ichinomiya
country: Japan
facility: Local Institution - 506
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
city: Itabashi-ku
country: Japan
facility: Local Institution - 511
city: Kagoshima
country: Japan
facility: Local Institution - 515
city: Kagoshima
country: Japan
facility: Saruwatari Dermatology Clinic
city: Kofu
country: Japan
facility: Local Institution - 513
city: Kofu
country: Japan
facility: Yamanashi Prefectual Central Hospital
city: Kyoto-City
country: Japan
facility: Local Institution - 505
city: Kyoto-City
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsudo
country: Japan
facility: Charme-Clinique
city: Matsudo
country: Japan
facility: Local Institution - 510
city: Nagoya
country: Japan
facility: Local Institution - 508
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Obihiro
country: Japan
facility: Local Institution - 512
city: Obihiro
country: Japan
facility: Takagi Dermatology
city: Osaka
country: Japan
facility: Local Institution - 517
city: Osaka
country: Japan
facility: Nakatsu Hifuka Clinic
city: Sapporo-shi, Hokkaido
country: Japan
facility: Local Institution - 500
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Skin Clinic
city: Sapporo
country: Japan
facility: Local Institution - 501
city: Sapporo
country: Japan
facility: Medical Corporation Kojinkai Housui Sogo Medical Clinic
city: Shinjuku
country: Japan
facility: Local Institution - 502
city: Shinjuku
country: Japan
facility: Tokyo Medical University Hospital
city: Yokohoma City, Kanagawa
country: Japan
facility: Local Institution - 509
city: Yokohoma City, Kanagawa
country: Japan
facility: Nomura Dermatology Clinic
city: Gdansk
country: Poland
facility: Copernicus Podmiot Leczniczy Sp. z o.o.
city: Gdansk
country: Poland
facility: Local Institution - 310
city: Katowice
country: Poland
facility: Care Clinic
city: Katowice
country: Poland
facility: Local Institution - 309
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Katowice
country: Poland
facility: Local Institution - 306
city: Lodz
country: Poland
facility: Centrum Medyczne Dermoklinika
city: Lodz
country: Poland
facility: Local Institution - 311
city: Olsztyn
country: Poland
facility: Local Institution - 312
city: Olsztyn
country: Poland
facility: Miejski Szpital Zespolony w Olsztynie
city: Ostrowiec Świętokrzyski
country: Poland
facility: Klinika Zdybski
city: Ostrowiec Świętokrzyski
country: Poland
facility: Local Institution - 300
city: Szczecin
country: Poland
facility: Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
city: Szczecin
country: Poland
facility: Local Institution - 308
city: Szczecin
country: Poland
facility: Local Institution - 302
city: Szczecin
country: Poland
facility: Twoja Przychodnia Szczecinskie Centrum Medyczne
city: Warsaw
country: Poland
facility: High-Med Przychodnia Specjalistyczna
city: Warsaw
country: Poland
facility: Local Institution - 301
city: Warsaw
country: Poland
facility: Klinika Ambroziak Estederm
city: Warsaw
country: Poland
facility: Local Institution - 307
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny
city: Wroclaw
country: Poland
facility: Centrum Zdrowia WroMedica
city: Wroclaw
country: Poland
facility: Local Institution - 305
city: Wrocław
country: Poland
facility: Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
city: Wrocław
country: Poland
facility: Local Institution - 304
city: Łódź
country: Poland
facility: Local Institution - 303
city: Łódź
country: Poland
facility: Specjalistyczne Gabinety Lekarskie DERMED
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: