A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

Phase 2

Completed

• Conditions: Crohn Disease; Colitis, Ulcerative
• Interventions: Drug: TEV-48574; Drug: Placebo

• Registration Number: NCT05499130
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.

Secondary objectives:

* To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures

* To evaluate the safety and tolerability of the 2 different dose regimens

* To evaluate the immunogenicity of the 2 different dose regimens

The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2022-08-29
• Primary Completion: 2024-11-12
• Study Completion: 2024-11-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
• The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
• The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
• Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
• Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer

NOTE- Additional criteria apply, please contact the investigator for more information

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Exclusion Criteria

• The participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician
• Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
• Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
• Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
• Participant anticipates requiring major surgery during this study.
• A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
• A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
• A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
• A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
• The participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
• Presence of a transplanted organ
• A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
• Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
• Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent

NOTE- Additional criteria apply, please contact the investigator for more information

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEV-48574 Dose A (UC)	TEV-48574	Dose regimen A administered by subcutaneous infusion for participants with UC
TEV-48574 Dose B (UC)	TEV-48574	Dose regimen B administered by Subcutaneous infusion for participants with UC
TEV-48574 Dose A (CD)	TEV-48574	Dose regimen A administered by subcutaneous infusion for participants with CD
TEV-48574 Dose B (CD)	TEV-48574	Dose regimen B administered by subcutaneous infusion for participants with CD
Placebo UC	Placebo	Matching Placebo
Placebo CD	Placebo	Matching Placebo

Primary Outcome Measures

Name	Time	Method
Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score	Week 14	Clinical remission is a modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: * stool frequency subscore of 0 or 1,; * rectal bleeding subscore of 0, and; * endoscopic subscore of 0 or 1, where a score of 1 does not include "friability" Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity) and the total score from 0 to 9, respectively
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease	Week 14	Endoscopic response defined as a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline

Secondary Outcome Measures

Name	Time	Method
Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score	Baseline and Week 14	Clinical response at week 14, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score	Week 14	Endoscopic remission defined as a Mayo endoscopic subscore of 0
Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index (CDAI)	Baseline, Weeks 4, 8, 12 and 14	Clinical response defined as a ≥100-point decrease in CDAI score
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score	Week 14	Clinical remission defined as a CDAI score less than 150
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score	Baseline and Week 14	Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency)
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score	Week 14	Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale
Number of Participants Who Experience Adverse Events	Baseline up to Week 18	Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score	Week 14	Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1
Number of participants with moderate to severe UC with a clinical response as defined as a decrease from baseline in 2-item patient-reported outcome (PRO2)	Baseline and Week 14	Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)	Baseline and Week 14	Endoscopic response defined as a decrease from baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of \>50%. The MM-SES-CD takes into account the chances of each parameter (presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures) achieving endoscopic remission.
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events	Up to Week 18
Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score	Week 14	Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)	Baseline, Weeks 2, 4, 8, 14, and 18
Number of ADA positive participants with the presence of neutralizing ADA	Weeks 2, 4, 8, 14, and 18

Trial Locations

Locations (164)

Teva Investigational Site 15568; 🇺🇸 Sun City, Arizona, United States

Teva Investigational Site 15556; 🇺🇸 San Diego, California, United States

Teva Investigational Site 15747; 🇺🇸 San Diego, California, United States

Teva Investigational Site 15357; 🇺🇸 Kissimmee, Florida, United States

Teva Investigational Site 15748; 🇺🇸 Miami, Florida, United States

Teva Investigational Site 15375; 🇺🇸 Orlando, Florida, United States

Teva Investigational Site 15359; 🇺🇸 Pinellas Park, Florida, United States

Teva Investigational Site 15566; 🇺🇸 Glenview, Illinois, United States

Teva Investigational Site 15567; 🇺🇸 Gurnee, Illinois, United States

Teva Investigational Site 15574; 🇺🇸 New Albany, Indiana, United States

Teva Investigational Site 15563; 🇺🇸 Miami, Florida, United States

Teva Investigational Site 15365; 🇺🇸 Miami, Florida, United States

Teva Investigational Site 15362; 🇺🇸 Iowa City, Iowa, United States

Teva Investigational Site 15367; 🇺🇸 Kansas City, Kansas, United States

Teva Investigational Site 15368; 🇺🇸 Louisville, Kentucky, United States

Teva Investigational Site 15575; 🇺🇸 Louisville, Kentucky, United States

Teva Investigational Site 15363; 🇺🇸 Columbia, Maryland, United States

Teva Investigational Site 15358; 🇺🇸 Liberty, Missouri, United States

Teva Investigational Site 15373; 🇺🇸 Saint Louis, Missouri, United States

Teva Investigational Site 15360; 🇺🇸 Austin, Texas, United States

Teva Investigational Site 15369; 🇺🇸 Las Vegas, Nevada, United States

Teva Investigational Site 15558; 🇺🇸 North Massapequa, New York, United States

Teva Investigational Site 15370; 🇺🇸 Chapel Hill, North Carolina, United States

Teva Investigational Site 15750; 🇺🇸 Beavercreek, Ohio, United States

Teva Investigational Site 15557; 🇺🇸 Greenville, South Carolina, United States

Teva Investigational Site 15573; 🇺🇸 Cordova, Tennessee, United States

Teva Investigational Site 15371; 🇺🇸 Dallas, Texas, United States

Teva Investigational Site 15366; 🇺🇸 Katy, Texas, United States

Teva Investigational Site 15743; 🇺🇸 Lubbock, Texas, United States

Teva Investigational Site 15569; 🇺🇸 Garland, Texas, United States

Teva Investigational Site 15559; 🇺🇸 Harlingen, Texas, United States

Teva Investigational Site 15372; 🇺🇸 Pearland, Texas, United States

Teva Investigational Site 15374; 🇺🇸 San Antonio, Texas, United States

Teva Investigational Site 37134; 🇧🇪 Edegem, Belgium

Teva Investigational Site 15565; 🇺🇸 Southlake, Texas, United States

Teva Investigational Site 15361; 🇺🇸 Tyler, Texas, United States

Teva Investigational Site 37133; 🇧🇪 Liege, Belgium

Teva Investigational Site 59243; 🇧🇬 Gorna Oryahovitsa, Bulgaria

Teva Investigational Site 59197; 🇧🇬 Sofia, Bulgaria

Teva Investigational Site 59199; 🇧🇬 Sofia, Bulgaria

Teva Investigational Site 15364; 🇺🇸 Salt Lake City, Utah, United States

Teva Investigational Site 33055; 🇦🇹 Innsbruck, Austria

Teva Investigational Site 33056; 🇦🇹 Vienna, Austria

Teva Investigational Site 59198; 🇧🇬 Pleven, Bulgaria

Teva Investigational Site 54220; 🇨🇿 Slany, Czechia

Teva Investigational Site 54242; 🇨🇿 Zabreh, Czechia

Teva Investigational Site 59196; 🇧🇬 Sofia, Bulgaria

Teva Investigational Site 11257; 🇨🇦 Winnipeg, Manitoba, Canada

Teva Investigational Site 54221; 🇨🇿 Brno, Czechia

Teva Investigational Site 54222; 🇨🇿 Klatovy, Czechia

Teva Investigational Site 54241; 🇨🇿 Prague, Czechia

Teva Investigational Site 35280; 🇫🇷 Caen, France

Teva Investigational Site 35295; 🇫🇷 Nantes, France

Teva Investigational Site 35277; 🇫🇷 Nice, France

Teva Investigational Site 35279; 🇫🇷 Saint-Priest-en-Jarez, France

Teva Investigational Site 81053; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 81057; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 81052; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 81056; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 81054; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 81055; 🇬🇪 Tbilisi, Georgia

Teva Investigational Site 32796; 🇩🇪 Berlin, Germany

Teva Investigational Site 32872; 🇩🇪 Berlin, Germany

Teva Investigational Site 32873; 🇩🇪 Duisburg, Germany

Teva Investigational Site 32793; 🇩🇪 Kiel, Germany

Teva Investigational Site 32797; 🇩🇪 Leipzig, Germany

Teva Investigational Site 32795; 🇩🇪 Tuebingen, Germany

Teva Investigational Site 32794; 🇩🇪 Ulm, Germany

Teva Investigational Site 32874; 🇩🇪 Wipperfuerth, Germany

Teva Investigational Site 51334; 🇭🇺 Budapest, Hungary

Teva Investigational Site 51335; 🇭🇺 Budapest, Hungary

Teva Investigational Site 51336; 🇭🇺 Gyongyos, Hungary

Teva Investigational Site 51333; 🇭🇺 Szekesfehervar, Hungary

Teva Investigational Site 51338; 🇭🇺 Vac, Hungary

Teva Investigational Site 80179; 🇮🇱 Afula, Israel

Teva Investigational Site 80191; 🇮🇱 Beer-Sheva, Israel

Teva Investigational Site 80184; 🇮🇱 Holon, Israel

Teva Investigational Site 80180; 🇮🇱 Rehovot, Israel

Teva Investigational Site 80182; 🇮🇱 Kfar Saba, Israel

Teva Investigational Site 30304; 🇮🇹 Brescia, Italy

Teva Investigational Site 30286; 🇮🇹 Milan, Italy

Teva Investigational Site 84114; 🇯🇵 Chiba, Japan

Teva Investigational Site 84112; 🇯🇵 Fukuoka, Japan

Teva Investigational Site 84110; 🇯🇵 Kashiwa-shi, Japan

Teva Investigational Site 84118; 🇯🇵 Nagoya, Japan

Teva Investigational Site 30285; 🇮🇹 Milan, Italy

Teva Investigational Site 30303; 🇮🇹 San Donato Milanese, Italy

Teva Investigational Site 30301; 🇮🇹 Turin, Italy

Teva Investigational Site 30284; 🇮🇹 Rozzano, Italy

Teva Investigational Site 30300; 🇮🇹 San Giovanni Rotondo, Italy

Teva Investigational Site 84113; 🇯🇵 Osaka, Japan

Teva Investigational Site 84117; 🇯🇵 Tokyo, Japan

Teva Investigational Site 84116; 🇯🇵 Tokyo, Japan

Teva Investigational Site 84115; 🇯🇵 Tokyo, Japan

Teva Investigational Site 84111; 🇯🇵 Toyama, Japan

Teva Investigational Site 41015; 🇳🇴 Lorenskog, Norway

Teva Investigational Site 41014; 🇳🇴 Tromso, Norway

Teva Investigational Site 53565; 🇵🇱 Bydgoszcz, Poland

Teva Investigational Site 53542; 🇵🇱 Czestochowa, Poland

Teva Investigational Site 53543; 🇵🇱 Elblag, Poland

Teva Investigational Site 53544; 🇵🇱 Gdansk, Poland

Teva Investigational Site 53545; 🇵🇱 Gdynia, Poland

Teva Investigational Site 53571; 🇵🇱 Jelenia Gora, Poland

Teva Investigational Site 53546; 🇵🇱 Katowice, Poland

Teva Investigational Site 53547; 🇵🇱 Klodzko, Poland

Teva Investigational Site 53560; 🇵🇱 Krakow, Poland

Teva Investigational Site 53548; 🇵🇱 Krakow, Poland

Teva Investigational Site 53512; 🇵🇱 Krakow, Poland

Teva Investigational Site 53511; 🇵🇱 Leczna, Poland

Teva Investigational Site 53515; 🇵🇱 Lodz, Poland

Teva Investigational Site 53514; 🇵🇱 Lodz, Poland

Teva Investigational Site 53518; 🇵🇱 Nowy Targ, Poland

Teva Investigational Site 53559; 🇵🇱 Opole, Poland

Teva Investigational Site 53572; 🇵🇱 Piotrkow Trybunalski, Poland

Teva Investigational Site 53517; 🇵🇱 Poznan, Poland

Teva Investigational Site 53516; 🇵🇱 Poznan, Poland

Teva Investigational Site 53566; 🇵🇱 Poznan, Poland

Teva Investigational Site 53513; 🇵🇱 Rzeszow, Poland

Teva Investigational Site 53550; 🇵🇱 Sopot, Poland

Teva Investigational Site 53551; 🇵🇱 Staszow, Poland

Teva Investigational Site 53508; 🇵🇱 Szczecin, Poland

Teva Investigational Site 53519; 🇵🇱 Szczecin, Poland

Teva Investigational Site 53552; 🇵🇱 Tarnow, Poland

Teva Investigational Site 53573; 🇵🇱 Tarnow, Poland

Teva Investigational Site 53553; 🇵🇱 Torun, Poland

Teva Investigational Site 53554; 🇵🇱 Wadowice, Poland

Teva Investigational Site 53557; 🇵🇱 Warsaw, Poland

Teva Investigational Site 53570; 🇵🇱 Warsaw, Poland

Teva Investigational Site 53556; 🇵🇱 Warsaw, Poland

Teva Investigational Site 53555; 🇵🇱 Warsaw, Poland

Teva Investigational Site 53558; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53562; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53510; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53567; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53520; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53549; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53563; 🇵🇱 Wroclaw, Poland

Teva Investigational Site 53509; 🇵🇱 Zamosc, Poland

Teva Investigational Site 62098; 🇸🇰 Banska Bystrica, Slovakia

Teva Investigational Site 62074; 🇸🇰 Bardejov, Slovakia

Teva Investigational Site 62073; 🇸🇰 Bratislava, Slovakia

Teva Investigational Site 62071; 🇸🇰 Kosice, Slovakia

Teva Investigational Site 62076; 🇸🇰 Presov, Slovakia

Teva Investigational Site 62097; 🇸🇰 Presov, Slovakia

Teva Investigational Site 62099; 🇸🇰 Rimavska Sobota, Slovakia

Teva Investigational Site 62072; 🇸🇰 Sahy, Slovakia

Teva Investigational Site 31325; 🇪🇸 Alicante, Spain

Teva Investigational Site 31302; 🇪🇸 Cordoba, Spain

Teva Investigational Site 31293; 🇪🇸 Huelva, Spain

Teva Investigational Site 31301; 🇪🇸 Las Palmas de Gran Canaria, Spain

Teva Investigational Site 31318; 🇪🇸 Santiago de Compostela, Spain

Teva Investigational Site 31291; 🇪🇸 Seville, Spain

Teva Investigational Site 31292; 🇪🇸 Valencia, Spain

Teva Investigational Site 58327; 🇺🇦 Chernivtsi, Ukraine

Teva Investigational Site 58324; 🇺🇦 Ivano-Frankivsk, Ukraine

Teva Investigational Site 58329; 🇺🇦 Lviv, Ukraine

Teva Investigational Site 58325; 🇺🇦 Lviv, Ukraine

Teva Investigational Site 58332; 🇺🇦 Lviv, Ukraine

Teva Investigational Site 58328; 🇺🇦 Ternopil, Ukraine

Teva Investigational Site 58322; 🇺🇦 Uzhhorod, Ukraine

Teva Investigational Site 58323; 🇺🇦 Uzhhorod, Ukraine

Teva Investigational Site 58330; 🇺🇦 Vinnytsia, Ukraine

Teva Investigational Site 58331; 🇺🇦 Vinnytsia, Ukraine

Teva Investigational Site 34305; 🇬🇧 London, United Kingdom