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Dermatitis, AtopicPhase 2NCT04800315

A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing CC-93538 in people with Dermatitis, Atopic and Eczema, run by Celgene at 157 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Dermatitis, Atopic, Eczema
What is being tested?
CC-93538
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
157 sitesin 6 countries
Study dates
14 May 2021to 9 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

157 sites in 6 countries.

157 sites in 6 countries

United States62 sites

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209

  • Local Institution - 119

    Birmingham, Alabama, 35209

  • Cahaba Dermatology

    Birmingham, Alabama, 35244

  • Local Institution - 114

    Birmingham, Alabama, 35244

  • Total Vein and Skin, LLC

    Boynton Beach, Florida, 33437

  • Local Institution - 133

    Clarkston, Michigan, 48346

  • Skin Research Clarkston/Clarkston Dermatology

    Clarkston, Michigan, 48346

  • DS Research

    Clarksville, Indiana, 47129-2201

  • Local Institution - 115

    Clarksville, Indiana, 47129-2201

  • Local Institution - 106

    Delray Beach, Florida, 33484-6500

  • Palm Beach Dermatology Group

    Delray Beach, Florida, 33484-6500

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Local Institution - 105

    Fountain Valley, California, 92708

  • Icahn School of Medicine at Mount Sinai

    Great Neck, New York, 11021-5506

  • Local Institution - 130

    Great Neck, New York, 11021-5506

  • Local Institution - 112

    Hackensack, New Jersey, 07601-1974

  • Skin Laser and Surgery Specialists of New York and New Jersey LLC

    Hackensack, New Jersey, 07601-1974

  • Clinical Research Partners LLC

    Henrico, Virginia, 23233-1487

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas, 71913-6440

  • Local Institution - 129

    Hot Springs, Arkansas, 71913-6440

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46256

  • Local Institution - 110

    Indianapolis, Indiana, 46256

  • Clinical Partners, LLC

    Johnston, Rhode Island, 02919

  • Local Institution - 123

    Johnston, Rhode Island, 02919

  • JDR Dermatology Research, LLC

    Las Vegas, Nevada, 89148

  • Local Institution - 121

    Las Vegas, Nevada, 89148

  • DS Research

    Louisville, Kentucky, 40241

  • Local Institution - 117

    Louisville, Kentucky, 40241

  • International Clinical Research

    Murfreesboro, Tennessee, 37130

  • Local Institution - 100

    Murfreesboro, Tennessee, 37130

  • Local Institution - 126

    New York, New York, 10075

  • Sadick Research Group

    New York, New York, 10075

  • Central Sooner Research

    Norman, Oklahoma, 73069-6301

  • Local Institution - 111

    Norman, Oklahoma, 73069-6301

  • Local Institution - 137

    Omaha, Nebraska, 68144

  • Skin Specialists PC

    Omaha, Nebraska, 68144

  • Kansas City Dermatology P.A.

    Overland Park, Kansas, 66215-2377

  • Local Institution - 116

    Overland Park, Kansas, 66215-2377

  • Local Institution - 109

    Portland, Oregon, 97223

  • Oregon Medical Research Center, P.C.

    Portland, Oregon, 97223

  • Local Institution - 104

    Richmond, Virginia, 23233-1436

  • West End Dermatology Associates

    Richmond, Virginia, 23233-1436

  • Aeroallergy Research Labs of Savannah

    Savannah, Georgia, 31406-2668

  • Local Institution - 134

    Savannah, Georgia, 31406-2668

  • DermAssociates

    Silver Spring, Maryland, 20902-5006

  • Local Institution - 125

    Silver Spring, Maryland, 20902-5006

  • Local Institution - 108

    Springfield, Illinois, 62702-5115

  • Sneeze Wheeze and Itch Associates LLC

    Springfield, Illinois, 62702-5115

  • GCP Global Clinical Professionals

    St. Petersburg, Florida, 33702

  • Local Institution - 135

    St. Petersburg, Florida, 33702

  • ForCare Clinical Research

    Tampa, Florida, 33624-2038

  • Local Institution - 101

    Tampa, Florida, 33624-2038

  • Local Institution - 127

    Tulsa, Oklahoma, 74136-8303

  • Vital Prospects Clinical Research Institute PC - CRN - PPDS

    Tulsa, Oklahoma, 74136-8303

  • George Washington University School of Medicine and Health Sciences

    Washington D.C., District of Columbia, 20037-3201

  • Local Institution - 128

    Washington D.C., District of Columbia, 20037-3201

  • Local Institution - 107

    West Lafayette, Indiana, 47906-1569

  • Randall Dermatology

    West Lafayette, Indiana, 47906-1569

  • Local Institution - 103

    West Palm Beach, Florida, 33401-3430

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401-3430

  • Local Institution - 138

    Westfield, Indiana, 46074

  • Randall Dermatology - Westfield Campus

    Westfield, Indiana, 46074

Other trials in United States

Japan30 sites

  • Local Institution - 514

    Fukuoka, 8140180

  • Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

    Fukuoka, 815-8588

  • Local Institution - 504

    Fukuoka, 815-8588

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka, 814-0180

  • Ichinomiya Municipal Hospital

    Ichinomiya, 491-8558

  • Local Institution - 506

    Ichinomiya, 491-8558

  • Local Institution - 515

    Kagoshima, 890-0055

  • Saruwatari Dermatology Clinic

    Kagoshima, 890-0055

  • Local Institution - 513

    Kofu, 400-0027

  • Yamanashi Prefectual Central Hospital

    Kofu, 400-0027

  • Local Institution - 505

    Kyoto, 602-8566

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Charme-Clinique

    Matsudo, 270-2223

  • Local Institution - 510

    Matsudo, 270-2223

  • Local Institution - 508

    Nagoya, 467-8602

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • Local Institution - 512

    Obihiro, 080-0013

  • Takagi Dermatology

    Obihiro, 080-0013

  • Local Institution - 517

    Osaka, Osaka

  • Nakatsu Hifuka Clinic

    Osaka, Osaka

  • Local Institution - 501

    Sapporo, 060-0063

  • Medical Corporation Kojinkai Housui Sogo Medical Clinic

    Sapporo, 060-0063

  • Local Institution - 500

    Sapporo-shi, Hokkaido, 060-0063

  • Sapporo Skin Clinic

    Sapporo-shi, Hokkaido, 060-0063

  • Local Institution - 502

    Shinjuku, 160-0023

  • Tokyo Medical University Hospital

    Shinjuku, 160-0023

  • Teikyo University Hospital

    tabashi City, 173-8606

  • Local Institution - 511

    tabashi City, 1738606

  • Local Institution - 509

    Yokohoma City, Kanagawa, 221-0825

  • Nomura Dermatology Clinic

    Yokohoma City, Kanagawa, 221-0825

Other trials in Japan

Poland27 sites

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

  • Local Institution - 310

    Gdansk, 80-803

  • Care Clinic

    Katowice, 40-568

  • Local Institution - 309

    Katowice, 40-568

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Local Institution - 306

    Katowice, 40-611

  • Local Institution - 303

    Lodz, 90-265

  • Specjalistyczne Gabinety Lekarskie DERMED

    Lodz, 90-265

  • Centrum Medyczne Dermoklinika

    Lodz, 90-436

  • Local Institution - 311

    Lodz, 90-436

  • Local Institution - 312

    Olsztyn, 10-229

  • Miejski Szpital Zespolony w Olsztynie

    Olsztyn, 10-229

  • Klinika Zdybski

    Ostrowiec Świętokrzyski, 27-400

  • Local Institution - 300

    Ostrowiec Świętokrzyski, 27-400

  • Laser Clinic Dermatologia Laserowa Medycyna Estetyczna

    Szczecin, 70-332

  • Local Institution - 308

    Szczecin, 70-332

  • Local Institution - 302

    Szczecin, 71-434

  • Twoja Przychodnia Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • High-Med Przychodnia Specjalistyczna

    Warsaw, 01-817

  • Local Institution - 301

    Warsaw, 01-817

  • Klinika Ambroziak Estederm

    Warsaw, 02-953

  • Local Institution - 307

    Warsaw, 02-953

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

  • Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie

    Wroclaw, 50-367

  • Local Institution - 304

    Wroclaw, 50-367

  • Centrum Zdrowia WroMedica

    Wroclaw, 51-685

  • Local Institution - 305

    Wroclaw, 51-685

Other trials in Poland

Canada18 sites

  • Institute for Skin Advancement

    Calgary, Alberta, T3A 2N1

  • Local Institution - 203

    Calgary, Alberta, T3A 2N1

  • Local Institution - 213

    Edmonton, Alberta, T6G 1C3

  • Rao Dermatology

    Edmonton, Alberta, T6G 1C3

  • Local Institution - 208

    Markham, Ontario, L3P IX3

  • Lynderm Research Inc

    Markham, Ontario, L3P IX3

  • DermEdge

    Mississauga, Ontario, L4Y 4C5

  • Local Institution - 211

    Mississauga, Ontario, L4Y 4C5

  • Local Institution - 209

    Oakville, Ontario, L6J 7W5

  • The Centre for Clinical Trials Inc.

    Oakville, Ontario, L6J 7W5

  • Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

    Québec, G1V 4X7

  • Local Institution - 202

    Québec, G1V 4X7

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7

  • Local Institution - 207

    Surrey, British Columbia, V3R 6A7

  • Enverus Medical Research

    Surrey, British Columbia, V3V 0C6

  • Local Institution - 200

    Surrey, British Columbia, V3V 0C6

  • Local Institution - 205

    Winnipeg, Manitoba, R3M 3Z4

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Czechia16 sites

  • Kozni ambulance Kutna Hora

    Kutná Hora, 284 01

  • Local Institution - 407

    Kutná Hora, 284 01

  • Dermamedica

    Náchod, 547 01

  • Local Institution - 403

    Náchod, 547 01

  • CCBR Ostrava

    Ostrava, 702 00

  • Local Institution - 404

    Ostrava, 702 00

  • Center for Clinical and Basic Research Czech Pardubice

    Pardubice, 530 02

  • Local Institution - 405

    Pardubice, 530 02

  • Clintrial

    Prague, 100 00

  • Local Institution - 402

    Prague, 100 00

  • CCBR Czech Prague s.r.o.

    Prague, 130 00

  • Local Institution - 400

    Prague, 130 00

  • FN Motol

    Prague, 15006

  • Local Institution - 401

    Prague, 15006

  • Dermatologicka Ambulance MUDr. Petr Trestik

    Svitavy, 568 02

  • Local Institution - 406

    Svitavy, 568 02

Other trials in Czechia

China4 sites

  • Kawashima Dermatology

    Ichikawa, 272-0033

  • Local Institution - 503

    Ichikawa, 272-0033

  • Local Institution - 507

    Matsudo, 271-0092

  • Miyata Dermatology Clinic

    Matsudo, 271-0092

Other trials in China

About this study

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

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).

Being tested
CC-93538, Placebo
Keywords
Atopic Dermatitis, Cendakimab, CC-93538
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-93538Drug

    Also called RPC4064, cendakimab

    Specified dosages on specified days

  • PlaceboOther

    Specified dosages on specified days

Study groups in NCT04800315
Study groupRoleWhat they receive
Dose 1: CC-93538 SC QWExperimentalAdministration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks.
Receives: Drug: CC-93538
Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2WExperimentalStarting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind.
Receives: Drug: CC-93538; Other: Placebo
Dose 3: CC-93538 SC Q2W and Placebo SC weeklyExperimentalStarting 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.
Receives: Drug: CC-93538; Other: Placebo
Placebo SC QWPlacebo comparatorAdministration of placebo each week.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From initial EASI measurement to week 16

Secondary outcomes (12)

  1. 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).

    Measured: From initial vIGA-AD assessment to week 16

  2. 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).

    Measured: From initial EASI measurement to week 16

  3. 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).

    Measured: From initial EASI measurement to week 16

  4. 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.

    Measured: From initial SCORAD measurement to week 16

  5. 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").

    Measured: From initial NRS measurement to week 16

  6. 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).

    Measured: From initial NRS assessment to week 16

  7. 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").

    Measured: From initial NRS pruritus response up to study day 127 (127 days)

  8. 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.

    Measured: From initial BSA assessment to week 16

  9. Number of Participants With Treatment Emergent Adverse Events

    Treatment emergent adverse events

    Measured: From first treatment to the end of follow up, approximately 32 weeks

  10. Number of Participants With the Presence of Serum Antibodies to CC-93538

    Measured: From first treatment to the end of follow up, approximately 32 weeks

  11. 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.

    Measured: At week 16

  12. Number of Participants With Clinically Significant Laboratory Abnormalities

    Measured: From first treatment to the end of follow up, approximately 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2021
  2. Study start14 May 2021
  3. Primary completion20 Jul 2022
  4. Study completion9 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04800315
Sponsor's protocol ID
CC-93538-AD-001
Other IDs
1111-1260-5462, 2020-005212-22
Status last verified
Dec 2023
First submitted
12 Mar 2021
Last updated
3 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 39018038

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CC-93538 in people with Dermatitis, Atopic and Eczema, run by Celgene at 157 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Japan, Poland, Canada, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage Change From Baseline in EASI at Week 16 (time frame: From initial EASI measurement to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04800315, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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