A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

NCT04753697 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CC-93538-EE-001U1111-1263-43512020-004336-16
• Study Type: interventional
• Target: 430
• Locations: 14 countries
• Sites: 209

Brief Summary

Study CC-93538-EE-001 is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC- 93538 in adult and adolescent participants with eosinophilic esophagitis (EoE). The study will incorporate a 24-week Induction Phase followed by a 24-week Maintenance Phase. Participants will be randomized at the beginning of the study into 3 treatment arms:

• Placebo for Induction and Maintenance
• CC-93538 360 mg Subcutaneous (SC) once weekly for Induction followed by 360 mg SC once every other week for Maintenance
• CC-93538 360 mg SC once weekly for Induction and Maintenance

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; CC-93538; RPC4046; Adult; Adolescent; Gastrointestinal Diseases; Esophagitis; Gastroenteritis; Eosinophils; Eosinophilia; Esophageal Diseases; Allergic Diseases; Antibody, Monoclonal; Hypersensitivity; Immunologic factors; Physiological Effects of Drugs; cendakimab

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Dysphagia Days (DD) at Week 24

  Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.

  Baseline (Day 1) and Week 24

• Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 24

  Blood samples were collected to assess esophageal eosinophil count.

  Week 24

Secondary Outcomes (31)

• Percentage of Participants With Peak Esophageal Eosinophil Count <= 6/High-power Field (Hpf) at Week 48

  Week 48

• Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 24

  Week 24

• Percentage of Participants With Peak Esophageal Eosinophil Count < 15/High-power Field (Hpf) at Week 48

  Week 48

• Change From Baseline in Mean Dysphagia Days (DD) at Week 48

  Baseline (Day 1) and Week 48

• Change From Baseline in Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS) at Week 24

  Baseline (Day 1) , Week 24

Study Arms (3)

Administration of CC-93538

EXPERIMENTAL

CC-93538 360 mg Subcutaneously (SC) once weekly for 24 weeks followed by CC-93538 360 mg SC once weekly for 24 weeks

Drug: CC-93538

Administration of CC-93538 and Placebo

EXPERIMENTAL

CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks. During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind.

Drug: CC-93538; Other: Placebo

Administration of Placebo

PLACEBO COMPARATOR

Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks

Other: Placebo

Interventions

CC-93538 DRUG

Subcutaneous

Also known as: RPC4046

Administration of CC-93538; Administration of CC-93538 and Placebo

Placebo OTHER

Subcutaneous

Administration of CC-93538 and Placebo; Administration of Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• Male or female patients aged ≥ 12 and ≤ 75 years, with a body weight of \> 40 kg.
• Histologic evidence of eosinophilic esophagitis, defined as a peak count of ≥ 15 eosinophils/high-power field at 2 levels of the esophagus.
• Participant-reported history of 4 or more Dysphagia Days within 2 consecutive weeks prior to end of screening.
• \. Lack of complete response to an adequate trial of proton pump inhibitor (8 weeks). Participants on a proton pump inhibitor must have been on a stable dose for at least 4 weeks prior to first Screening Visit and agree to continue the same dose throughout the study.
• \. Participants currently receiving inhaled corticosteroids, leukotriene receptor antagonists, or mast cell stabilizers for indications other than EoE, or medium potency topical corticosteroids for dermatologic conditions, must maintain stable doses for at least 4 weeks prior to the first Screening Visit and throughout the duration of the study.
• \. Participants must agree to maintain a stable diet (including any food elimination diet for the treatment of food allergy or eosinophilic esophagitis) and not introduce any changes in their diet from the first Screening Visit to the end of the study.
• \. Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose.

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Clinical or endoscopic evidence of other diseases that may affect the histologic, endoscopic, and clinical symptom evaluation for this study.
• Other gastrointestinal disorders such as active Helicobacter pylori infection, esophageal varices, gastritis, colitis, celiac disease, Mendelian disorder associated with eosinophilic esophagitis, liver function impairment, or a known hereditary fructose intolerance.
• Evidence of a severe endoscopic structural abnormality in the esophagus.
• Esophageal dilation for symptom relief within 8 weeks prior to first Screening Visit or during the Screening Period, or if esophageal dilation is anticipated within 48 weeks of dosing during the study.
• Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to the first Screening Visit.
• Treatment with a high potency topical corticosteroid for dermatologic use, or a systemic corticosteroid within 8 weeks of the first Screening Visit.
• Treatment with a swallowed topical corticosteroid, leukotriene receptor antagonist, or mast cell stabilizer for EoE, within 4 weeks of the first Screening Visit.
• Treatment with oral or sublingual immunotherapy within 6 months of the first Screening Visit (any use will be prohibited during the study). Subcutaneous immunotherapy may be allowed if on stable doses for at least 3 months prior to the first Screening Visit and during the study.
• Actively successful dietary modification adherence (e.g. food elimination diet), resulting in a complete response to EoE.
• Prior treatment with CC-93538 during a Phase 1 or 2 clinical study.
• Receipt of a live attenuated vaccine within 4 weeks of the first Screening Visit.
• Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic disorder or psychiatric illness that compromises the Participant's ability to accurately document symptoms of eosinophilic esophagitis).
• Active or ongoing infections including parasitic/helminthic, hepatitis, tuberculosis, or human immunodeficiency virus.
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks of the first Screening Visit.

Sponsors & Collaborators

• Celgene: lead

Study Sites (212)

Local Institution - 144

Birmingham, Alabama, 35211-1320, United States

Location

Local Institution - 158

Tuscaloosa, Alabama, 35406, United States

Location

Local Institution - 082

Phoenix, Arizona, 85016, United States

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Local Institution - 147

Phoenix, Arizona, 85020-4348, United States

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Local Institution - 041

Scottsdale, Arizona, 85259, United States

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Local Institution - 029

Tucson, Arizona, 85715, United States

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Local Institution - 165

North Little Rock, Arkansas, 72117, United States

Location

Local Institution - 075

Lancaster, California, 93534, United States

Location

Local Institution - 047

Los Angeles, California, 90067, United States

Location

Local Institution - 084

Oakland, California, 94609, United States

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Local Institution - 160

San Diego, California, 92103-5639, United States

Location

Local Institution - 068

Aurora, Colorado, 80045, United States

Location

Local Institution - 067

Colorado Springs, Colorado, 80907, United States

Location

Local Institution - 092

Denver, Colorado, 80218, United States

Location

Local Institution - 170

Littleton, Colorado, 80120-5641, United States

Location

Local Institution - 128

Wheat Ridge, Colorado, 80033, United States

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Local Institution - 101

Bristol, Connecticut, 06010, United States

Location

Local Institution - 076

Farmington, Connecticut, 06030, United States

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Local Institution - 156

Hamden, Connecticut, 06518, United States

Location

Local Institution - 099

Clearwater, Florida, 33756-3839, United States

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Local Institution - 036

Inverness, Florida, 34452, United States

Location

Local Institution - 042

Jacksonville, Florida, 32256, United States

Location

Local Institution - 161

Miami, Florida, 33032, United States

Location

Local Institution - 138

Miami, Florida, 33144-2035, United States

Location

Local Institution - 110

North Miami Beach, Florida, 33162, United States

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Local Institution - 146

Orlando, Florida, 32806-1041, United States

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Local Institution - 088

Orlando, Florida, 32806, United States

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Local Institution - 133

Orlando, Florida, 32825, United States

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Local Institution - 169

Pinellas Park, Florida, 33781-3228, United States

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Local Institution - 168

Plantation, Florida, 33324-3345, United States

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Local Institution - 037

Port Orange, Florida, 32127, United States

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Local Institution - 140

Sweetwater, Florida, 33172-2741, United States

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Local Institution - 043

Atlanta, Georgia, 30322, United States

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Local Institution - 171

Atlanta, Georgia, 30328, United States

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Local Institution - 054

Atlanta, Georgia, 30342, United States

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Local Institution - 117

Macon, Georgia, 31201, United States

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Local Institution - 024

Idaho Falls, Idaho, 83404, United States

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Local Institution - 039

Chicago, Illinois, 60611, United States

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Local Institution - 167

Gurnee, Illinois, 60031-5711, United States

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Local Institution - 118

Indianapolis, Indiana, 46202, United States

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Local Institution - 127

Clive, Iowa, 50325, United States

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Local Institution - 094

Iowa City, Iowa, 52242, United States

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Local Institution - 035

Kansas City, Kansas, 66160, United States

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Local Institution - 046

Florence, Kentucky, 41042, United States

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Local Institution - 019

Louisville, Kentucky, 40202, United States

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Local Institution - 003

Baton Rouge, Louisiana, 70809, United States

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Local Institution - 020

Metairie, Louisiana, 70006, United States

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Local Institution - 044

Metairie, Louisiana, 70006, United States

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Local Institution - 109

Baltimore, Maryland, 21224, United States

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Local Institution - 065

Catonsville, Maryland, 21228, United States

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Local Institution - 164

Columbia, Maryland, 21045, United States

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Local Institution - 070

Glen Burnie, Maryland, 21061, United States

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Local Institution - 012

Hagerstown, Maryland, 21742, United States

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Local Institution - 053

Boston, Massachusetts, 02111, United States

Location

Local Institution - 097

Boston, Massachusetts, 02114, United States

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Local Institution - 017

Framingham, Massachusetts, 01702, United States

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Local Institution - 083

South Dartmouth, Massachusetts, 02747, United States

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Local Institution - 081

Springfield, Massachusetts, 01199, United States

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Local Institution - 009

Worcester, Massachusetts, 01655, United States

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Local Institution - 098

Troy, Michigan, 48098, United States

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Local Institution - 014

Wyoming, Michigan, 49519, United States

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Local Institution - 115

Plymouth, Minnesota, 55446, United States

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Local Institution - 049

Rochester, Minnesota, 55905, United States

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Local Institution - 034

Flowood, Mississippi, 39232, United States

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Local Institution - 007

Kansas City, Missouri, 64111, United States

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Local Institution - 032

St Louis, Missouri, 63110-1010, United States

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Local Institution - 038

Omaha, Nebraska, 68198, United States

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Local Institution - 015

Lebanon, New Hampshire, 03756, United States

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Local Institution - 139

Albuquerque, New Mexico, 87106-4725, United States

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Local Institution - 028

Great Neck, New York, 11023, United States

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Local Institution - 051

New York, New York, 10016-4744, United States

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Local Institution - 154

New York, New York, 10017-2009, United States

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Local Institution - 011

New York, New York, 10029, United States

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Local Institution - 116

Syracuse, New York, 13210-2306, United States

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Local Institution - 142

Syracuse, New York, 13210, United States

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Local Institution - 016

Chapel Hill, North Carolina, 27599, United States

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Local Institution - 045

Charlotte, North Carolina, 28277, United States

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Local Institution - 106

Durham, North Carolina, 27705, United States

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Local Institution - 131

Greensboro, North Carolina, 27405-6950, United States

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Local Institution - 126

Kinston, North Carolina, 28501-3851, United States

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Local Institution - 130

Beavercreek, Ohio, 45440-3237, United States

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Local Institution - 006

Cincinnati, Ohio, 45219, United States

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Local Institution - 001

Cincinnati, Ohio, 45229, United States

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Local Institution - 052

Cincinnati, Ohio, 45267, United States

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Local Institution - 072

Cleveland, Ohio, 44195, United States

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Local Institution - 145

Columbus, Ohio, 43212-3119, United States

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Local Institution - 059

Columbus, Ohio, 43235, United States

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Local Institution - 166

Oklahoma City, Oklahoma, 73112-5550, United States

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Local Institution - 120

Hershey, Pennsylvania, 17033, United States

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Local Institution - 025

Philadelphia, Pennsylvania, 19104, United States

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Local Institution - 155

Pottsville, Pennsylvania, 17901-3636, United States

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Local Institution - 066

Providence, Rhode Island, 02905, United States

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Local Institution - 143

Anderson, South Carolina, 29621-2062, United States

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Local Institution - 057

Greenville, South Carolina, 29615, United States

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Local Institution - 114

Chattanooga, Tennessee, 37421, United States

Location

Local Institution - 095

Nashville, Tennessee, 37212, United States

Location

Local Institution - 105

Cedar Park, Texas, 78613, United States

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Local Institution - 148

Dallas, Texas, 75234-7858, United States

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Local Institution - 112

Houston, Texas, 77079-2211, United States

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Local Institution - 079

Rockwell, Texas, 75032, United States

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Local Institution - 008

San Antonio, Texas, 78229, United States

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Local Institution - 077

Southlake, Texas, 76092, United States

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Local Institution - 104

Tyler, Texas, 75701, United States

Location

Local Institution - 157

Draper, Utah, 84020-5645, United States

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Local Institution - 125

Ogden, Utah, 84403-3323, United States

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Local Institution - 074

Salt Lake City, Utah, 84132, United States

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Local Institution - 027

Leesburg, Virginia, 20176, United States

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Local Institution - 013

Lynchburg, Virginia, 24502, United States

Location

Local Institution - 064

Richmond, Virginia, 23249, United States

Location

Local Institution - 134

Roanoke, Virginia, 24013, United States

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Local Institution - 137

Spokane, Washington, 99218, United States

Location

Local Institution - 023

Vancouver, Washington, 98664, United States

Location

Local Institution - 085

Milwaukee, Wisconsin, 53215, United States

Location

Local Institution - 060

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 121

Casper, Wyoming, 10456, United States

Location

Local Institution - 697

Buenos Aires, C1199ABB, Argentina

Location

Local Institution - 695

Mar del Plata, B7600DHK, Argentina

Location

Local Institution - 696

Quilmes, B1878DVB, Argentina

Location

Local Institution - 548

Concord, New South Wales, 2139, Australia

Location

Local Institution - 554

Liverpool, New South Wales, 2170, Australia

Location

Local Institution - 540

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 546

Maroorchydore, Queensland, 4558, Australia

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Local Institution - 550

South Brisbane, Queensland, 4101, Australia

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Local Institution - 542

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 552

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 545

Elizabeth Vale, South Australia, 05112, Australia

Location

Local Institution - 553

Clayton, Victoria, 3168, Australia

Location

Local Institution - 543

Footscray, Victoria, 3011, Australia

Location

Local Institution - 539

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 549

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 538

Fitzroy, 3065, Australia

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Local Institution - 547

Western Australia, 6056, Australia

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Local Institution - 437

Burgenland, 7000, Austria

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Local Institution - 434

Graz, 8036, Austria

Location

Local Institution - 436

Linz, 4010, Austria

Location

Local Institution - 515

Brussels, 1090, Belgium

Location

Local Institution - 516

Kortrijk, 8500, Belgium

Location

Local Institution - 514

Leuven, 3000, Belgium

Location

Local Institution - 512

West-Vlaanderen, 8310, Belgium

Location

Local Institution - 201

Calgary, Alberta, T2N 2T9, Canada

Location

Local Institution - 208

Edmonton, Alberta, T5R 1W2, Canada

Location

Local Institution - 205

Edmonton, Alberta, T6K 4B2, Canada

Location

Local Institution - 203

Vancouver, British Columbia, V6Z 2K5, Canada

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Local Institution - 206

Victoria, British Columbia, V8V3M9, Canada

Location

Local Institution - 207

Ottawa, Ontario, K1H 1E4, Canada

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Local Institution - 200

Vaughan, Ontario, L4L 4Y7, Canada

Location

Local Institution - 330

Bayern, 82418, Germany

Location

Local Institution - 332

Brandenburg, 14770, Germany

Location

Local Institution - 339

Frankfurt am Main, 60313, Germany

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Local Institution - 336

Hamburg, 20249, Germany

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Local Institution - 333

Leipzig, 04103, Germany

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Local Institution - 338

Leipzig, 04129, Germany

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Local Institution - 340

München, 80639, Germany

Location

Local Institution - 337

München, 81675, Germany

Location

Local Institution - 281

Haifa, 3109601, Israel

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Local Institution - 283

Holon, 5822012, Israel

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Local Institution - 280

Jerusalem, 91031, Israel

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Local Institution - 282

Jerusalem, 91120, Israel

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Local Institution - 278

Tel Aviv, 64239, Israel

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Local Institution - 279

Ẕerifin, 70300, Israel

Location

Local Institution - 257

Genova, 16132, Italy

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Local Institution - 254

Milan, 20122, Italy

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Local Institution - 255

Padua, 35128, Italy

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Local Institution - 252

Pisa, 56100, Italy

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Local Institution - 253

Rome, 00161, Italy

Location

Local Institution - 600

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 595

Bunkyo-ku, Tokyo, 113-8603, Japan

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Local Institution - 599

Setagaya-ku, Tokyo, 157-8535, Japan

Location

Local Institution - 593

Akita, 010-8543, Japan

Location

Local Institution - 606

Isehara City, Kanagawa, 259-1193, Japan

Location

Local Institution - 597

Kobe, 650-0017, Japan

Location

Local Institution - 598

Maebashi, 371-8511, Japan

Location

Local Institution - 604

Nagoya, 457-8511, Japan

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Local Institution - 607

Nagoya, 467-8602, Japan

Location

Local Institution - 592

Niigata, 951-8510, Japan

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Local Institution - 603

Okayama, 700-8505, Japan

Location

Local Institution - 591

Osaka, 545-8586, Japan

Location

Local Institution - 601

Shibukawa, 377-8577, Japan

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Local Institution - 602

Shinjuku-Ku, 162-8655, Japan

Location

Local Institution - 605

Tokyo, 108-8329, Japan

Location

Local Institution - 596

Toyoake, 470-1192, Japan

Location

Local Institution - 590

Yamagata, 990-9585, Japan

Location

Local Institution - 385

Bydgoszcz, 85-079, Poland

Location

Local Institution - 389

Częstochowa, 42-202, Poland

Location

Local Institution - 390

Gdansk, 80-382, Poland

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Local Institution - 388

Katowice, 40-040, Poland

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Local Institution - 392

Lódz, 90-127, Poland

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Local Institution - 387

Warsaw, 00-189, Poland

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Local Institution - 393

Warsaw, 01-192, Poland

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Local Institution - 383

Warsaw, 04-501, Poland

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Local Institution - 391

Wroclaw, 50-381, Poland

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Local Institution - 386

Wroclaw, 50-556, Poland

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Local Institution - 384

Wroclaw, 51-162, Poland

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Local Institution - 307

Lisbon, 1169-045, Portugal

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Local Institution - 305

Lisbon, 1649-035, Portugal

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Local Institution - 306

Porto, 4099-001, Portugal

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Local Institution - 308

Porto, 4200-319, Portugal

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Local Institution - 408

Barcelona, 08036, Spain

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Local Institution - 410

Córdoba, 14001, Spain

Location

Local Institution - 409

Madrid, 28006, Spain

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Local Institution - 413

Madrid, 28046, Spain

Location

Local Institution - 411

Marbella, 29603, Spain

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Local Institution - 412

Seville, 41013, Spain

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Local Institution - 357

Lausanne, 1011, Switzerland

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Local Institution - 228

Belfast Northern Ireland, BT9 7AB, United Kingdom

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Local Institution - 231

Birmingham, B15 2SQ, United Kingdom

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Local Institution - 234

Cardiff, CF15 9SS, United Kingdom

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Local Institution - 235

Chorley, PR7 7NA, United Kingdom

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Local Institution - 233

Hexam, NE46 1QJ, United Kingdom

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Local Institution - 236

Liverpool, L22 0LG, United Kingdom

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Local Institution - 237

Manchester, M15 6SX, United Kingdom

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Local Institution - 226

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• Dellon ES, Charriez CM, Zhang S, Falk GW, Oliva S, Ma C, Siffledeen J, Schroeder S, Philpott H, Vanuytsel T, Abe Y, Li K, Zema CL, Venkatasamy A, Yeshokumar AK, Oh YS, Schoepfer A. Cendakimab in Adults and Adolescents with Eosinophilic Esophagitis. NEJM Evid. 2025 Oct;4(10):EVIDoa2500095. doi: 10.1056/EVIDoa2500095. Epub 2025 Sep 23.

  PMID: 40985784 DERIVED

• Charriez CM, Zhang S, de Oliveira CHMC, Patel V, Oh YS, Hirano I, Schoepfer A, Dellon ES. Design of a phase 3, randomized, double-blind, placebo-controlled, 48-week study to evaluate the efficacy and safety of cendakimab in adult and adolescent patients with eosinophilic esophagitis. Contemp Clin Trials. 2024 Dec;147:107708. doi: 10.1016/j.cct.2024.107708. Epub 2024 Oct 9.

  PMID: 39384067 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Eosinophilic Esophagitis; Gastrointestinal Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Esophageal Diseases; Hypersensitivity

Interventions

cendakimab

Condition Hierarchy (Ancestors)

Digestive System Diseases; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 15, 2021
• Study Start: February 22, 2021
• Primary Completion: January 11, 2024
• Study Completion: August 29, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AU (14); PT (4); US (115); CA (7); AR (3); IL (6); DE (8); BE (4); ES (6); PL (11); IT (5); GB (8); CH (1); JP (17)