Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC

NCT03298022 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 2017.008.01
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 12

Brief Summary

To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or anti-integrin treatments.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients With Clinical Response at Week 12

  The clinical response is defined as a ≥ 3-point reduction in Mayo Clinic Score, a 30% or greater decrease from the baseline score, and with a 1-point or greater decrease of the rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1, The colonic site with maximum inflammation was determined by Mayo endoscopic subscore (MES) defined as follows: normal (0 points); erythema, decreased vascular pattern, mild friability (1 point); absent vascular pattern, friability, erosions (2 points); and spontaneous bleeding or ulceration (3 points). Lower score means disease improvement.

  week 12

Secondary Outcomes (8)

• The Proportion of Patients With Clinical Response (mITT)

  weeks 6,16, 20 and 26

• The Proportion of Patients With Clinical Remission

  weeks 6,16, 20 and 26

• Flexible Sigmoidoscopy Subscore Changes From Baseline

  Baseline, week 12- and week 26 after the first treatment

• The Number of Patients With Mucosal Healing

  at 12- and 26-week after the first treatment

• Change of Histological Activity Grade From Baseline Using the Geboes System

  at 12- and 26-week after the first treatment

Other Outcomes (2)

• CRP Changes From Baseline (CFB) (Exploratory)

  Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26

• Changes in Fecal Calprotectin (CFB) - Exploratory Biomarker

  Am 4, Weeks 4, 9, 12, 16, 20, 26; Am 1-3 weeks 4,8,12,16,20, 26

Study Arms (1)

ALTB-168

EXPERIMENTAL

intravenous doses of ALTB-168

Biological: ALTB-168

Interventions

ALTB-168 BIOLOGICAL

monoclonal antibody

Also known as: Neihulizumab

ALTB-168

Eligibility Criteria

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

You may qualify if:

• Patients must provide written informed consent;
• Age 18-75 years;
• Diagnosis of UC ≥ 12 weeks prior to screening by full colonoscopy (i.e., ≥ 12 weeks after first diagnosis by a physician according to American College of Gastroenterology guidelines);
• Moderate-to-severe active UC, at time of screening, defined as:
• Mayo Clinic Score (MCS) of 6 points or higher, AND
• a centrally read MCS endoscopic subscore of grade 2 or higher, AND
• MCS rectal bleeding subscore of 1 point or higher, AND
• disease extending 15 cm or more from the anal verge;
• Stable doses of concomitant medications, including :
• Stable oral corticosteroids (i.e., ≤ 20 mg/day of prednisone, ≤ 9 mg/day of budesonide) ≥ 2 weeks before D1 dosing; Taper of oral corticosteroids per Investigator's discretion during the study is allowed;
• Stable oral 5-amyinosalicylic acid dose ≥ 2 weeks before D1 dosing;
• Stable immunosuppressant including azathioprine, mercaptopurine, or methotrexate ≥ 8 weeks before D1 dosing. Patients taking methotrexate also are advised to take folic acid 1 mg/day or equivalent if there is no contraindication;
• Stable doses of probiotics ≥ 2 weeks before D1 dosing;
• Stable anti-diarrheas ≥ 2 weeks before D1 dosing;
• Patients must have previously received anti-tumor necrosis factor alpha (anti- TNF alpha and/or anti-integrin therapy for UC and demonstrated an inadequate response, loss of response, or intolerance, and must have discontinued therapy ≥ 8 weeks before D1 dosing;

You may not qualify if:

• Indeterminate colitis (Inflammatory bowel disease unclassified, IBD-U) or suspected Crohn's disease
• Any history of colectomy
• Presence of an ileostomy or colostomy
• A history or evidence of colonic mucosal dysplasia
• Short gut syndrome
• Pregnant or lactating
• Inability to comply with study protocol in the opinion of the investigator
• History of dysplasia or malignancy in recent 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Cirrhosis or active alcohol abuse per the judgement of investigator
• Poorly controlled diabetes (HbA1c \> 8.0%)
• Significant screening ECG abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block
• Impaired renal function (calculated creatinine clearance \< 60 mL/min)
• Impaired hepatic function in the absence of diagnosis of primary sclerosing cholangitis, serum transaminase \> 2.5x Upper Limit Normal (ULN), alkaline phosphatase \> 2.5x ULN, or increased total bilirubin judged by the investigator to be clinically significant, or a diagnosis of primary sclerosing cholangitis, serum transaminases \> 3x ULN, alkaline phosphatase \> 3x ULN, or total bilirubin \> 2.5x ULN judged by the investigator to be clinically significant
• Moderate to severe anemia (Hb \< 8g/dL)
• Thrombocytopenia (platelet count \< 75,000/uL)

Sponsors & Collaborators

• AltruBio Inc.: lead

Study Sites (12)

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72205, United States

Location

Stomach Doctor - Surinder Saini, MD - Fountain Valley

Newport Beach, California, 92660, United States

Location

Wellness Clinical Research (WCR)

Hialeah, Florida, 33016-2202, United States

Location

Wellness Clinical Research (WCR)

Lake Wales, Florida, 33853, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Capitol Research

Rockville, Maryland, 20850, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington Medical Center (UWMC) - Digestive Disease Center

Seattle, Washington, 98195, United States

Location

Wellness Clinical Research (WCR)

Vega Baja, 00694, Puerto Rico

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Vice President of Clinical Operations
• Organization: AltruBio

simona.reed@altrubio.com

17142150224

Study Officials

• Shih-Yao Lin, MD, PhD

  AltruBio Inc.

  STUDY DIRECTOR

• David T Rubin, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: September 29, 2017
• Study Start: May 4, 2018
• Primary Completion: April 6, 2020
• Study Completion: June 1, 2020
• Last Updated: January 5, 2024
• Results First Posted: July 6, 2023

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); PR (1)