NCT03599622

Brief Summary

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2018

Longer than P75 for phase_2

Geographic Reach
26 countries

259 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

4.4 years

First QC Date

July 11, 2018

Results QC Date

May 30, 2024

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Percent of Participants Achieving Clinical Remission at Week 12

    Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

    12 weeks after first dose

  • Percent of Participants Achieving Endoscopic Response at Week 12

    Endoscopic Response is defined as \>= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.

    12 weeks after first dose

Secondary Outcomes (3)

  • Percent of Participants Achieving Clinical Response at Week 12

    12 weeks after first dose

  • Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12

    12 weeks after first dose

  • Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12

    12 weeks after first dose

Study Arms (3)

BMS-986165 Dose 1

EXPERIMENTAL
Drug: BMS-986165

BMS-986165 Dose 2

EXPERIMENTAL
Drug: BMS-986165

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Specified dose on specified days

BMS-986165 Dose 1BMS-986165 Dose 2
PlaceboOTHER

Specified dose on specified days

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution
  • Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments
  • Must have active moderate to severe CD
  • Men and women must agree to follow specific methods of contraception, if applicable

You may not qualify if:

  • Severe or fulminant colitis that is likely to require surgery or hospitalization
  • Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease
  • Previous exposure to BMS-986165 in any study
  • Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (259)

Local Institution - 0258

Los Angeles, California, 90067-2015, United States

Location

Local Institution - 0247

Aurora, Colorado, 80014, United States

Location

Local Institution - 0001

Hamden, Connecticut, 06518, United States

Location

Local Institution - 0255

Clearwater, Florida, 33756-3839, United States

Location

Local Institution - 0259

Jacksonville, Florida, 32207-4958, United States

Location

Local Institution - 0261

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0276

Largo, Florida, 33777, United States

Location

Local Institution - 0232

Miami, Florida, 33136, United States

Location

Local Institution - 0162

New Port Richey, Florida, 34653, United States

Location

Local Institution - 0201

Orlando, Florida, 32808, United States

Location

Local Institution - 0249

Orlando, Florida, 32832, United States

Location

Local Institution - 0166

Tampa, Florida, 33606, United States

Location

Local Institution - 0248

Zephyrhills, Florida, 33542, United States

Location

Local Institution - 0277

Suwanee, Georgia, 30024, United States

Location

Local Institution - 0358

Suwanee, Georgia, 30024, United States

Location

Local Institution - 0319

Chicago, Illinois, 60637, United States

Location

Local Institution - 0346

Glenview, Illinois, 60026, United States

Location

Local Institution - 0301

Indianapolis, Indiana, 46202, United States

Location

Local Institution - 0253

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0282

Shreveport, Louisiana, 71105, United States

Location

Local Institution - 0003

Chesterfield, Michigan, 48047, United States

Location

Local Institution - 0218

Chesterfield, Michigan, 48047, United States

Location

Local Institution - 0047

Wyoming, Michigan, 49519, United States

Location

Local Institution - 0223

Ypsilanti, Michigan, 48197, United States

Location

Local Institution - 0231

Jackson, Mississippi, 39216, United States

Location

Local Institution - 0156

Ocean Springs, Mississippi, 39564, United States

Location

Local Institution - 0359

St Louis, Missouri, 63130, United States

Location

Local Institution - 0011

Las Vegas, Nevada, 89123, United States

Location

Local Institution - 0043

Lake Success, New York, 11042, United States

Location

Local Institution - 0308

New York, New York, 10032, United States

Location

Local Institution - 0226

Monroe, North Carolina, 28112, United States

Location

Local Institution - 0349

Oklahoma City, Oklahoma, 73112, United States

Location

Local Institution - 0238

Hershey, Pennsylvania, 17033, United States

Location

Local Institution - 0125

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0122

Sayre, Pennsylvania, 18840, United States

Location

Local Institution - 0357

Wyomissing, Pennsylvania, 19610, United States

Location

Local Institution - 0105

Charleston, South Carolina, 29406, United States

Location

Local Institution - 0072

Nashville, Tennessee, 37204, United States

Location

Local Institution - 0264

Arlington, Texas, 76012, United States

Location

Local Institution - 0246

Garland, Texas, 75044, United States

Location

Local Institution - 0252

San Antonio, Texas, 78229, United States

Location

Local Institution - 0307

San Antonio, Texas, 78229, United States

Location

Local Institution - 0073

Southlake, Texas, 76092, United States

Location

Local Institution - 0240

Spring, Texas, 77379, United States

Location

Local Institution - 0302

Tyler, Texas, 75701, United States

Location

Local Institution

Lynchburg, Virginia, 24502, United States

Location

Local Institution - 0224

Richmond, Virginia, 23249, United States

Location

Local Institution - 0327

Seattle, Washington, 98101, United States

Location

Local Institution - 0266

Seattle, Washington, 98104, United States

Location

Local Institution - 0191

Seattle, Washington, 98195, United States

Location

Local Institution - 0331

Vancouver, Washington, 98664, United States

Location

Local Institution - 0356

Milwaukee, Wisconsin, 53215-5217, United States

Location

Local Institution - 0268

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0254

Woolloongabba, Queensland, 4102, Australia

Location

Local Institution - 0265

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0289

Woodville, South Australia, 5011, Australia

Location

Local Institution - 0042

Ballarat, Victoria, 3350, Australia

Location

Local Institution - 0041

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0040

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0351

Melbourne, Victoria, 3181, Australia

Location

Local Institution - 0275

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0316

Antwerp, 2018, Belgium

Location

Local Institution - 0305

Edegem, 2650, Belgium

Location

Local Institution - 0322

Ghent, 9000, Belgium

Location

Local Institution - 0314

Yvoir, 5530, Belgium

Location

Local Institution - 0256

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Local Institution - 0262

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Local Institution - 0069

Juiz de Fora, Minas Gerais, 26033-318, Brazil

Location

Local Institution - 0086

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Local Institution - 0058

Botucato, São Paulo, 18618-970, Brazil

Location

Local Institution - 0059

Santo André, São Paulo, 09060-650, Brazil

Location

Local Institution - 0045

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Local Institution - 0085

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Local Institution - 0017

Rio de Janeiro, 21941-913, Brazil

Location

Local Institution - 0048

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution - 0324

Edmonton, Alberta, T5R 1W2, Canada

Location

Local Institution - 0300

Edmonton, Alberta, T6K 4B2, Canada

Location

Local Institution - 0159

Vancouver, British Columbia, V5Z1M9, Canada

Location

Local Institution - 0283

Etobicoke, Ontario, M9V 4B8, Canada

Location

Local Institution - 0312

London, Ontario, N6A 5A5, Canada

Location

Local Institution - 0236

Toronto, Ontario, M4N 3M5, Canada

Location

Local Institution - 0317

Montreal, Quebec, H3G 1A4, Canada

Location

Local Institution - 0280

Xiamen, Fujian, 361004, China

Location

Local Institution - 0225

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0228

Guangzhou, Guangdong, 510655, China

Location

Local Institution - 0221

Changsha, Hunan, 410011, China

Location

Local Institution - 0220

Nanjing, Jiangsu, 210011, China

Location

Local Institution - 0306

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0250

Changchun, Jilin, 130033, China

Location

Local Institution - 0299

Shenyang, Liaoning, 110022, China

Location

Local Institution - 0219

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution - 0234

Shanghai, Shanghai Municipality, 200120, China

Location

Local Institution - 0337

Brno, 602 00, Czechia

Location

Local Institution - 0360

Brno, 602 00, Czechia

Location

Local Institution - 0057

Hradec Králové, 500 12, Czechia

Location

Local Institution - 0352

Ostrava, 702 00, Czechia

Location

Local Institution - 0071

Ostrava, 708 52, Czechia

Location

Local Institution - 0350

Pardubice, 532 03, Czechia

Location

Local Institution - 0075

Prague, 190 00, Czechia

Location

Local Institution - 0192

Aalborg, 9210, Denmark

Location

Local Institution - 0202

Copenhagen NV, 2400, Denmark

Location

Local Institution - 0320

Odense, 5000, Denmark

Location

Local Institution - 0110

Clichy, 92110, France

Location

Local Institution - 0168

Colombes, 92701, France

Location

Local Institution - 0343

Montpellier, 34295, France

Location

Local Institution - 0084

Saint-Etienne, 42055, France

Location

Local Institution - 0127

Toulouse, 31059, France

Location

Local Institution - 0167

Toulouse, 31300, France

Location

Local Institution - 0099

Berlin, 10117, Germany

Location

Local Institution - 0090

Berlin, 13353, Germany

Location

Local Institution - 0339

Brandenburg, 14770, Germany

Location

Local Institution - 0212

Frankfurt, 60590, Germany

Location

Local Institution - 0178

Halle, 06108, Germany

Location

Local Institution

Halle, 06120, Germany

Location

Local Institution - 0294

Hanover, 30625, Germany

Location

Local Institution - 0089

Jena, 07747, Germany

Location

Local Institution - 0190

Kiel, 24105, Germany

Location

Local Institution - 0321

Mannheim, 68167, Germany

Location

Local Institution - 0140

Münster, 48159, Germany

Location

Local Institution - 0257

Regensburg, D-93053, Germany

Location

Local Institution - 0340

Tübingen, 72076, Germany

Location

Local Institution - 0102

Ulm, 89081, Germany

Location

Local Institution - 0104

Békéscsaba, 5600, Hungary

Location

Local Institution - 0242

Budapest, 1062, Hungary

Location

Local Institution - 0263

Budapest, 1083, Hungary

Location

Local Institution - 0211

Budapest, 1088, Hungary

Location

Local Institution - 0100

Budapest, 1097, Hungary

Location

Local Institution - 0292

Budapest, 1136, Hungary

Location

Local Institution - 0054

Debrecen, 4032, Hungary

Location

Local Institution - 0083

Gyöngyös, 3200, Hungary

Location

Local Institution - 0210

Mohács, 7700, Hungary

Location

Local Institution - 0243

Szeged, 6725, Hungary

Location

Local Institution - 0164

Vác, 2600, Hungary

Location

Local Institution - 0348

Tallaght, Dublin, 0, Ireland

Location

Local Institution - 0335

Ballinasloe, Galway, H53 T971, Ireland

Location

Local Institution - 0336

Drogheda, Louth, A92 VW28, Ireland

Location

Local Institution - 0330

Dublin, D15 X40D, Ireland

Location

Local Institution - 0332

Galway, H91 yR71, Ireland

Location

Local Institution - 0197

Beersheba, 8410101, Israel

Location

Local Institution - 0186

Nahariya, 2210001, Israel

Location

Local Institution - 0184

Petah Tikva, 49100, Israel

Location

Local Institution - 0198

Rehovot, 7661041, Israel

Location

Local Institution - 0290

Bologna, 40138, Italy

Location

Local Institution - 0298

Castellana Grotte, 70013, Italy

Location

Local Institution - 0171

Catanzaro, 88100, Italy

Location

Local Institution - 0056

Messina, 98125, Italy

Location

Local Institution - 0304

Milan, 20122, Italy

Location

Local Institution - 0115

Milan, 20142, Italy

Location

Local Institution - 0311

Milan, 20157, Italy

Location

Local Institution - 0297

Monserrato, 09042, Italy

Location

Local Institution - 0310

Negrar, 37024, Italy

Location

Local Institution - 0128

Padua, 35128, Italy

Location

Local Institution - 0170

Pavia, 27100, Italy

Location

Local Institution - 0161

Roma, 00168, Italy

Location

Local Institution - 0119

Rozzano, 20089, Italy

Location

Local Institution - 0285

Torino, 10128, Italy

Location

Local Institution - 0182

Toyoake, Aichi-ken, 470-1192, Japan

Location

Local Institution - 0199

Hirosaki, Aomori, 036-8545, Japan

Location

Local Institution - 0205

Sakura-shi, Chiba, 285-8741, Japan

Location

Local Institution - 0328

Tōon, Ehime, 791-0295, Japan

Location

Local Institution - 0326

Fukui-shi, Fukui, 910-8526, Japan

Location

Local Institution - 0204

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Local Institution - 0187

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Local Institution - 0323

Sapporo, Hokkaido, 0608543, Japan

Location

Local Institution - 0217

Sapporo, Hokkaido, 065-0033, Japan

Location

Local Institution - 0183

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Local Institution - 0207

Sagamihara-shi, Kanagawa, 2520375, Japan

Location

Local Institution - 0200

Sendai, Miyagi, 983-8520, Japan

Location

Local Institution - 0194

Omura-shi, Nagasaki, 8568562, Japan

Location

Local Institution - 0318

Urasoe-Shi, Okinawa, 901-2132, Japan

Location

Local Institution - 0179

Suita-shi, Osaka, 5650871, Japan

Location

Local Institution - 0185

Ōtsu, Shiga, 520-2192, Japan

Location

Local Institution - 0189

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0213

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Local Institution - 0195

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0188

Hiroshima, 734-8551, Japan

Location

Local Institution - 0206

Kyoto, 6128555, Japan

Location

Local Institution - 0214

Miyazaki, 8891692, Japan

Location

Local Institution - 0196

Saga, 849-8501, Japan

Location

Local Institution - 0203

Sapporo, 0600033, Japan

Location

Local Institution - 0106

Guadalajara, Jalisco, 44500, Mexico

Location

Local Institution - 0007

Mexico City, Mexico City, 06700, Mexico

Location

Local Institution - 0009

Cuernavaca, Morelos, 62290, Mexico

Location

Local Institution - 0109

Monterrey, Nuevo León, 64060, Mexico

Location

Local Institution - 0029

Querétaro, 76070, Mexico

Location

Local Institution - 0303

Amsterdam, 1105 AZ, Netherlands

Location

Local Institution - 0245

Bydgoszcz, 85-231, Poland

Location

Local Institution - 0177

Bydgoszcz, 85-794, Poland

Location

Local Institution - 0065

Krakow, 31-501, Poland

Location

Local Institution - 0284

Lodz, 90-153, Poland

Location

Local Institution - 0098

Lodz, 90-302, Poland

Location

Local Institution - 0291

Lublin, 20-582, Poland

Location

Local Institution - 0278

Nowy Targ, 34-400, Poland

Location

Local Institution - 0176

Olsztyn, 10-117, Poland

Location

Local Institution - 0082

Sopot, 81-756, Poland

Location

Local Institution - 0063

Tychy, 43-100, Poland

Location

Local Institution - 0271

Warsaw, 00-728, Poland

Location

Local Institution - 0288

Warsaw, 02-507, Poland

Location

Local Institution - 0026

Warsaw, 03-580, Poland

Location

Local Institution - 0279

Warsaw, 04-141, Poland

Location

Local Institution - 0160

Wroclaw, 52-210, Poland

Location

Local Institution - 0034

Wroclaw, 52-416, Poland

Location

Local Institution - 0174

Guimarães, 4835-044, Portugal

Location

Local Institution - 0216

Santa Maria da Feira, 4520-211, Portugal

Location

Local Institution - 0067

Bucharest, 010719, Romania

Location

Local Institution - 0044

Bucharest, 020125, Romania

Location

Local Institution - 0163

Bucharest, 031784, Romania

Location

Local Institution - 0074

Bucharest, 050098, Romania

Location

Local Institution - 0005

Timișoara, 300002, Romania

Location

Local Institution - 0060

Timișoara, 300158, Romania

Location

Bioterm

Barnaul, 656015, Russia

Location

Hospital Irkutsk Scientific Center

Irkutsk, 664033, Russia

Location

Republican Clinical Hospital Ministry of Health Republic of Tatarstan

Kazan', 420064, Russia

Location

City Clinical Hospital Number 24

Moscow, 127015, Russia

Location

Medical Center SibNovoMed

Novosibirsk, 630005, Russia

Location

Novosibirsk Gastrocenter

Novosibirsk, 630007, Russia

Location

Novosibirsk State Regional Clinical Hospital

Novosibirsk, 630087, Russia

Location

Medical Center Healthy Family

Novosibirsk, 630099, Russia

Location

Clinic Ultrasound 4D

Pyatigorsk, 357502, Russia

Location

Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, 195257, Russia

Location

Saratov Regional Clinical Hospital

Saratov, 410038, Russia

Location

Tomsk Regional Clinical Hospital

Tomsk, 634063, Russia

Location

Multidisciplinary Consultative and Diagnostic Center

Tyumen, 625026, Russia

Location

Novgorod Regional Clinical Hospital

Veliky Novgorod, 173008, Russia

Location

Local Institution - 0046

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Local Institution - 0158

Ansan-si, 152-703, South Korea

Location

Local Institution - 0149

Busan, 48108, South Korea

Location

Local Institution - 0064

Daegu, 42415, South Korea

Location

Local Institution - 0061

Daegu, 700-721, South Korea

Location

Local Institution - 0150

Incheon, 22332, South Korea

Location

Local Institution - 0015

Seoul, 03181, South Korea

Location

Local Institution - 0016

Seoul, 06591, South Korea

Location

Local Institution - 0012

Wŏnju, 26426, South Korea

Location

Local Institution - 0032

Yangsan, 50612, South Korea

Location

Local Institution - 0329

Alicante, 03011, Spain

Location

Local Institution - 0274

Barcelona, 08036, Spain

Location

Local Institution - 0154

Fuenlabrada, 28942, Spain

Location

Local Institution - 0080

Girona, 17007, Spain

Location

Local Institution - 0021

Las Palmas de Gran Canaria, 35010, Spain

Location

Local Institution

LHospitalet de Llobregat, 08907, Spain

Location

Local Institution - 0325

Sabadell, 08208, Spain

Location

Local Institution - 0113

Santander, 39008, Spain

Location

Local Institution - 0309

Santiago de Compostelle, 15702, Spain

Location

Local Institution - 0313

Seville, 41009, Spain

Location

Local Institution - 0107

Seville, 41013, Spain

Location

Local Institution - 0004

Valencia, 46010, Spain

Location

Local Institution - 0180

Bern, CH-3012, Switzerland

Location

Local Institution - 0173

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0148

Taichung, 404, Taiwan

Location

Local Institution - 0267

Taipei, 10002, Taiwan

Location

Local Institution - 0152

Taoyuan District, 333, Taiwan

Location

Local Institution - 0341

Birmingham, B9 5SS, United Kingdom

Location

Local Institution - 0144

Blackpool, FY3 8NR, United Kingdom

Location

Local Institution - 0235

Cambridge, CB2 0QQ, United Kingdom

Location

Local Institution - 0354

Cannock, WS11 0BN, United Kingdom

Location

Local Institution - 0165

Cheshire, WA5 1QG, United Kingdom

Location

Local Institution - 0157

Glasgow, G51 4TF, United Kingdom

Location

Local Institution - 0353

Manchester, M13 9NQ, United Kingdom

Location

Local Institution - 0208

Swansea, SA6 6NL, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Limitations and Caveats

Trial terminated because of lack of efficacy in the short term acute phase.

Results Point of Contact

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

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 2
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

July 11, 2018

First Posted

July 26, 2018

Study Start

July 16, 2018

Primary Completion

December 12, 2022

Study Completion

October 23, 2023

Last Updated

July 3, 2024

Results First Posted

July 3, 2024

Record last verified: 2024-06

Locations