A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

NCT04700449 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CBP-307CN002
• Study Type: interventional
• Target: 145
• Locations: 4 countries
• Sites: 66

Brief Summary

This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).

Conditions

Moderate to Severe Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline for Adapted Mayo Score: 0.2 mg Versus Placebo

  Change in adapted Mayo score from baseline at week 12 compared between CBP-307 0.2 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.

  The adapted Mayo score was evaluated at screening and Week 12 (or early termination visit) during the study Stage 1 as well as at Week 24 (only for the sub-study 2) and Week 48 (or early termination visit) during the study Stage 2.

Secondary Outcomes (10)

• Change in Complete Mayo Score From Baseline

  at Week 12

• Comparison of Clinical Response Rate by Adapted Mayo Score

  at Week 12

• Comparison of Clinical Response Rate by Complete Mayo Score

  at Week 12

• Comparison of Clinical Remission Rate by Adapted Mayo Score

  at Week 12

• Comparison of Clinical Remission Rate by Complete Mayo Score

  at Week 12

Study Arms (4)

Double-Blind 0.2mg CBP-307

EXPERIMENTAL

0.2 mg CBP-307 capsules oral administration.

Drug: Double-Blind 0.2mg CBP-307

Double-Blind Placebo

PLACEBO COMPARATOR

Placebo capsules oral administration.

Drug: Double-Blind Placebo

Open-Label CBP-307

EXPERIMENTAL

0.2 mg CBP-307 capsules oral administration.

Drug: Open-label CBP-307

Double-Blind 0.1mg CBP-307

EXPERIMENTAL

0.1 mg CBP-307 capsules oral administration.

Drug: Double-Blind 0.1mg CBP-307

Interventions

Double-Blind 0.2mg CBP-307 DRUG

0.2 mg capsule oral administration

Double-Blind 0.2mg CBP-307

Double-Blind Placebo DRUG

Placebo capsule oral administration

Double-Blind Placebo

Open-label CBP-307 DRUG

0.2 mg capsule oral administration

Open-Label CBP-307

Double-Blind 0.1mg CBP-307 DRUG

0.1 mg capsule oral administration

Double-Blind 0.1mg CBP-307

Eligibility Criteria

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

You may not qualify if:

• Subjects were eligible to be included in the study only if all the following criteria applied:
• Male or female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC established at least 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report;
• Confirmed to have moderately to severely active UC within 14 days prior to the first dose of the investigational product, based on an adapted Mayo score of 4 to 9, and an endoscopic subscore of ≥2;
• Had evidence of UC extending to the rectum with ≥15 cm involvement on endoscopy;
• UC patients who were receiving treatment. Subjects could be enrolled if they met any items below:
• Prior to the randomization visit, subjects had received oral 5-aminosalicylic acid (5-ASA) (e.g., mesalazine, sulfasalazine, olsalazine, balsalazide) for at least 4 weeks with the dose stable for at least 2 weeks;
• Prior to the randomization visit, subjects had received oral or intravenous (IV) corticosteroids e.g. prednisone (daily doses ≤30 mg), budesonide (daily doses ≤9 mg), methylprednisolone (daily doses ≤24 mg), or equivalent dose of corticosteroids for at least 4 weeks, with the dose stable for at least 2 weeks;
• Oral 5-ASA or corticosteroid for treatment of UC had been stopped for at least 2 weeks prior to the screening endoscopy examination which was used for Mayo score assessment;
• A stable dosing regimen had to be used if non-prohibited concomitant medications were used.
• Subjects who met any of the following criteria were excluded:
• Subjects had evidence of toxic megacolon;
• Had subtotal or total colectomy;
• An existing ileostomy, colostomy, or known symptomatic stenosis of the intestine; a history or evidence of adenomatous colonic polyps that had not been removed; a history or evidence of colonic mucosal dysplasia including low or high grade of dysplasia, as well as indeterminate for dysplasia; a suspected or confirmed diagnosis of Crohn's enterocolitis, undiagnosed types of colitis, ischemic colitis, or radiation colitis;
• Previous exposure to lymphocyte-depleting therapies or D-penicillamine, leflunomide; prior exposure to approved or investigational products that inhibited the lymphocyte trafficking;
• Received immunosuppressants within 30 days prior to randomization; received any investigational biologic or non-biologic agent, or approved biologic agent or biosimilars within 60 days or 5 half lives prior to screening (whichever was longer);

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (66)

Connect Investigative Site 2316

Phoenix, Arizona, 85018, United States

Location

Connect Investigative Site 2308

Mission Hills, California, 91345, United States

Location

Connect Investigative Site 2314

Hialeah, Florida, 33016, United States

Location

Connect Investigative Site 2309

Homestead, Florida, 33032, United States

Location

Connect Investigative Site 2320

Kissimmee, Florida, 34741, United States

Location

Connect Investigative Site 2318

Miami, Florida, 33126, United States

Location

Connect Investigative Site 2302

Orlando, Florida, 32803, United States

Location

Connect Investigative Site 2304

Orlando, Florida, 32810, United States

Location

Connect Investigative Site 2306

Orlando, Florida, 32819, United States

Location

Connect Investigative Site 2307

Atlanta, Georgia, 30309, United States

Location

Connect Investigative Site 2315

Cincinnati, Ohio, 45219, United States

Location

Connect Investigative Site 2321

Oklahoma City, Oklahoma, 73102, United States

Location

Connect Investigative Site 2311

Cypress, Texas, 90212, United States

Location

Connect Investigative Site 2319

San Antonio, Texas, 78229, United States

Location

Connect Investigative Site 2018

Hefei, Anhui, 230001, China

Location

Connect Investigative Site 2004

Hefei, Anhui, 230022, China

Location

Connect Investigative Site 2008

Beijing, Beijing Municipality, 100050, China

Location

Connect Investigative Site 2001

Beijing, Beijing Municipality, 100730, China

Location

Connect Investigative Site 2015

Jilin, Changchun, 130021, China

Location

Connect Investigative Site 2006

Fuzhou, Fujian, 350001, China

Location

Connect Investigative Site 2012

Xiamen, Fujian, 361004, China

Location

Connect Investigative Site 2003

Guangzhou, Guangdong, 510120, China

Location

Connect Investigative Site 2009

Guangzhou, Guangdong, 510655, China

Location

Connect Investigative Site 2017

Shenzhen, Guangdong, 518035, China

Location

Connect Investigative Site 2021

Shenzhen, Guangdong, 518053, China

Location

Connect Investigative Site 2030

Nanning, Guangxi, 168600, China

Location

Connect Investigative Site 2034

Haikou, Hainan, 570311, China

Location

Connect Investigative Site 2026

Shijiazhuang, Hebei, 050000, China

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Connect Investigative Site 2041

Shijiazhuang, Hebei, 050011, China

Location

Connect Investigative Site 2022

Zhengzhou, Henan, 450052, China

Location

Connect Investigative Site 2016

Wuhan, Hubei, 430022, China

Location

Connect Investigative Site 2005

Wuhan, Hubei, 430030, China

Location

Connect Investigative Site 2027

Nanjing, Jiangsu, 210002, China

Location

Connect Investigative Site 2031

Nanjing, Jiangsu, 210006, China

Location

Connect Investigative Site 2023

Nanjing, Jiangsu, 210036, China

Location

Connect Investigative Site 2033

Suzhou, Jiangsu, 215004, China

Location

Connect Investigative Site 2046

Nanchang, Jiangxi, 330006, China

Location

Connect Investigative Site 2025

Dalian, Liaoning, 116027, China

Location

Connect Investigative Site 2040

Shenyang, Liaoning, 117004, China

Location

Connect Investigative Site 2028

Jinan, Shandong, 250012, China

Location

Connect Investigative Site 2044

Jinan, Shandong, China

Location

Connect Investigative Site 2024

Qingdao, Shandong, 266000, China

Location

Connect Investigative Site 2011

Shanghai, Shanghai Municipality, 200025, China

Location

Connect Investigative Site 2007

Shanghai, Shanghai Municipality, 200040, China

Location

Connect Investigative Site 2019

Shanghai, Shanghai Municipality, 200065, China

Location

Connect Investigative Site 2035

Shanghai, Shanghai Municipality, 200080, China

Location

Connect Investigative Site 2038

Shanghai, Shanghai Municipality, 200433, China

Location

Connect Investigative Site 2020

Taiyuan, Shanxi, 030001, China

Location

Connect Investigative Site 2013

Chengdu, Sichuan, 610041, China

Location

Connect Investigative Site 2043

Chongqing, Sichuan, 400037, China

Location

Connect Investigative Site 2047

Hangzhou, Zhejiang, 310003, China

Location

Connect Investigative Site 2032

Hangzhou, Zhejiang, 310009, China

Location

Connect Investigative Site 2045

Wenzhou, Zhejiang, 325027, China

Location

Connect Investigative Site 2151

Karachi, Sindh, 74800, Pakistan

Location

Connect Investigative Site 2152

Karachi, Sindh, 75270, Pakistan

Location

Connect Investigative Site 2211

Dnipro, 49005, Ukraine

Location

Connect Investigative Site 2217

Ivano-Frankivsk, 76018, Ukraine

Location

Connect Investigative Site 2202

Kharkiv, 61037, Ukraine

Location

Connect Investigative Site 2208

Kharkiv, 61124, Ukraine

Location

Connect Investigative Site 2205

Kyiv, 1135, Ukraine

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Connect Investigative Site 2220

Kyiv, 8173, Ukraine

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Connect Investigative Site 2215

Lviv, 79005, Ukraine

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Connect Investigative Site 2216

Lviv, 79010, Ukraine

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Connect Investigative Site 2218

Uzhhorod, 88000, Ukraine

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Connect Investigative Site 2209

Vinnytsia, 21021, Ukraine

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Connect Investigative Site 2214

Zaporizhzhia, 69035, Ukraine

Location

MeSH Terms

Interventions

Double-Blind Method

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: John Guo, Director of Clinical Operation
• Organization: Suzhou Connect Biopharmaceuticals, Ltd

jwguo@connectpharm.com

051253577866

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• 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: October 22, 2020
• First Posted: January 7, 2021
• Study Start: February 27, 2019
• Primary Completion: February 23, 2022
• Study Completion: November 10, 2022
• Last Updated: May 6, 2024
• Results First Posted: November 2, 2023

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); UA (11); PA (2); CN (39)