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

Crohn Disease Clinical Trial

— RELIEVE UCCD  

Official title:

A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499130
• Other study ID #: TV48574-IMM-20036
• Secondary ID: 2021-006881-19
• Status: Recruiting
• Phase: Phase 2
• Start date: August 29, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: May 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: Teva U.S. Medical Information
• Phone: 1-888-483-8279
• Email: USMedInfo[@]tevapharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 15, 2025
• Est. primary completion date: December 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Intervention

Drug:
• TEV-48574
Subcutaneous infusion
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Belgium	Teva Investigational Site 37134	Edegem
Belgium	Teva Investigational Site 37133	Liege
Bulgaria	Teva Investigational Site 59198	Pleven
Bulgaria	Teva Investigational Site 59196	Sofia
Bulgaria	Teva Investigational Site 59197	Sofia
Bulgaria	Teva Investigational Site 59199	Sofia
Canada	Teva Investigational Site 11259	Toronto	Ontario
Canada	Teva Investigational Site 11257	Winnipeg	Manitoba
Czechia	Teva Investigational Site 54221	Brno
Czechia	Teva Investigational Site 54222	Klatovy
Czechia	Teva Investigational Site 54220	Slany
France	Teva Investigational Site 35280	Caen cedex
France	Teva Investigational Site 35277	Nice Cedex 3
France	Teva Investigational Site 35279	Saint Etienne
Germany	Teva Investigational Site 32796	Berlin
Germany	Teva Investigational Site 32793	Kiel
Germany	Teva Investigational Site 32795	Tuebingen
Hungary	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
Israel	Teva Investigational Site 80179	Afula
Israel	Teva Investigational Site 80191	Beer Sheva
Israel	Teva Investigational Site 80184	Holon
Israel	Teva Investigational Site 80182	Kfar-Sava
Israel	Teva Investigational Site 80180	Rechovot
Italy	Teva Investigational Site 30284	Rozzano
Japan	Teva Investigational Site 84112	Fukuoka-shi
Japan	Teva Investigational Site 84110	Kashiwa-shi
Japan	Teva Investigational Site 84117	Minato-ku
Japan	Teva Investigational Site 84115	Mitaka-shi
Japan	Teva Investigational Site 84118	Nagoya-shi
Japan	Teva Investigational Site 84113	Osaka-shi
Japan	Teva Investigational Site 84114	Sakura-shi
Japan	Teva Investigational Site 84116	Shinjuku-ku
Japan	Teva Investigational Site 84111	Toyama-shi
Norway	Teva Investigational Site 41015	Lorenskog
Norway	Teva Investigational Site 41014	Tromso
Poland	Teva Investigational Site 53512	Krakow
Poland	Teva Investigational Site 53511	Leczna
Poland	Teva Investigational Site 53514	Lodz
Poland	Teva Investigational Site 53515	Lodz
Poland	Teva Investigational Site 53518	Nowy Targ
Poland	Teva Investigational Site 53516	Poznan
Poland	Teva Investigational Site 53517	Poznan
Poland	Teva Investigational Site 53513	Rzeszow
Poland	Teva Investigational Site 53551	Staszow
Poland	Teva Investigational Site 53508	Szczecin
Poland	Teva Investigational Site 53519	Szczecin
Poland	Teva Investigational Site 53555	Warszawa
Poland	Teva Investigational Site 53510	Wroclaw
Poland	Teva Investigational Site 53509	Zamosc
Serbia	Teva Investigational Site 62097	Presov
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 62072	Sahy
Spain	Teva Investigational Site 31293	Huelva
Spain	Teva Investigational Site 31318	Santiago de Compostela
Spain	Teva Investigational Site 31291	Sevilla
Spain	Teva Investigational Site 31292	Valencia
Ukraine	Teva Investigational Site 58327	Chernivtsi
Ukraine	Teva Investigational Site 58324	Ivano-Frankivsk
Ukraine	Teva Investigational Site 58325	Lviv
Ukraine	Teva Investigational Site 58329	Lviv
Ukraine	Teva Investigational Site 58332	Lviv
Ukraine	Teva Investigational Site 58328	Ternopil
Ukraine	Teva Investigational Site 58322	Uzhgorod
Ukraine	Teva Investigational Site 58323	Uzhgorod
Ukraine	Teva Investigational Site 58330	Vinnytsia
Ukraine	Teva Investigational Site 58331	Vinnytsia
United Kingdom	Teva Investigational Site 34305	London
United States	Teva Investigational Site 15360	Austin	Texas
United States	Teva Investigational Site 15564	Chandler	Arizona
United States	Teva Investigational Site 15370	Chapel Hill	North Carolina
United States	Teva Investigational Site 15363	Columbia	Maryland
United States	Teva Investigational Site 15573	Cordova	Tennessee
United States	Teva Investigational Site 15371	Dallas	Texas
United States	Teva Investigational Site 15751	Dallas	Texas
United States	Teva Investigational Site 15750	Dayton	Ohio
United States	Teva Investigational Site 15569	Garland	Texas
United States	Teva Investigational Site 15566	Glenview	Illinois
United States	Teva Investigational Site 15557	Greenville	South Carolina
United States	Teva Investigational Site 15559	Harlingen	Texas
United States	Teva Investigational Site 15362	Iowa City	Iowa
United States	Teva Investigational Site 15367	Kansas City	Kansas
United States	Teva Investigational Site 15366	Katy	Texas
United States	Teva Investigational Site 15357	Kissimmee	Florida
United States	Teva Investigational Site 15369	Las Vegas	Nevada
United States	Teva Investigational Site 15358	Leawood	Kansas
United States	Teva Investigational Site 15368	Louisville	Kentucky
United States	Teva Investigational Site 15743	Lubbock	Texas
United States	Teva Investigational Site 15365	Miami	Florida
United States	Teva Investigational Site 15563	Miami	Florida
United States	Teva Investigational Site 15748	Miami	Florida
United States	Teva Investigational Site 15574	New Albany	Indiana
United States	Teva Investigational Site 15575	New Albany	Indiana
United States	Teva Investigational Site 15558	North Massapequa	New York
United States	Teva Investigational Site 15375	Orlando	Florida
United States	Teva Investigational Site 15372	Pearland	Texas
United States	Teva Investigational Site 15373	Saint Louis	Missouri
United States	Teva Investigational Site 15364	Salt Lake City	Utah
United States	Teva Investigational Site 15374	San Antonio	Texas
United States	Teva Investigational Site 15556	San Diego	California
United States	Teva Investigational Site 15747	San Diego	California
United States	Teva Investigational Site 15565	Southlake	Texas
United States	Teva Investigational Site 15567	Southlake	Texas
United States	Teva Investigational Site 15568	Southlake	Texas
United States	Teva Investigational Site 15359	Tampa	Florida
United States	Teva Investigational Site 15361	Tyler	Texas
United States	Teva Investigational Site 15560	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Norway,  Poland,  Serbia,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score	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	Week 14
Primary	Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease	Endoscopic response defined as a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline	Week 14
Secondary	Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score	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	Baseline and Week 14
Secondary	Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score	Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1	Week 14
Secondary	Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score	Endoscopic remission defined as a Mayo endoscopic subscore of 0	Week 14
Secondary	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)	Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)	Baseline and Week 14
Secondary	Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score	Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale	Week 14
Secondary	Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index (CDAI)	Clinical response defined as a =100-point decrease in CDAI score	Baseline, Weeks 4, 8, 12 and 14
Secondary	Number of participants with moderate to severe CD in clinical remission as defined by CDAI score	Clinical remission defined as a CDAI score less than 150	Week 14
Secondary	Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score	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)	Baseline and Week 14
Secondary	Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score	Clinical remission defined as abdominal pain =1 and stool frequency =3 on the PRO2 scale	Week 14
Secondary	Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)	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.	Baseline and Week 14
Secondary	Number of Participants Who Experience Adverse Events	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.	Baseline up to Week 18
Secondary	Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events		Up to Week 18
Secondary	Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)		Baseline, Weeks 2, 4, 8, 14, and 18
Secondary	Number of ADA positive participants with the presence of neutralizing ADA		Weeks 2, 4, 8, 14, and 18