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A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

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ClinicalTrials.gov Identifier: NCT03695185
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of ABBV-323 in participants with moderate to severe UC who failed prior therapy.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: ABBV-323 Dose A Drug: ABBV-323 Dose B Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Estimated Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : October 16, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: ABBV-323
Participants administered with ABBV-323 dose A IV and ABBV-323 dose B for 12 Weeks. Participants who achieve clinical response may enter the maintenance period in which participants are administered with ABBV-323 dose B
Drug: ABBV-323 Dose A
ABBV-323 Dose A is intravenously (IV) administered.

Drug: ABBV-323 Dose B
ABBV-323 Dose B is administered subcutaneously (SC).

Experimental: Group 2: Placebo
Participants administered with Placebo IV and Placebo for 12 Weeks. Participants who achieve clinical response may enter the maintenance period in which participants are administered with ABBV-323 dose B
Drug: Placebo
Placebo is administered intravenously and subcutaneously.




Primary Outcome Measures :
  1. Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]
    Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1.


Secondary Outcome Measures :
  1. Percentage of participants with clinical remission per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) <=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0 , and endoscopic subscore <=1.

  2. Percentage of participants with clinical response per Adapted Mayo score [ Time Frame: At Week 8 ]
    Clinical response per Adapted Mayo score is defined as the decrease from Baseline >= 2 points and >= 30%, PLUS a decrease in RBS >=1 or an absolute RBS <=1.

  3. Percentage of participants with clinical response per Partial Adapted Mayo score [ Time Frame: Up to Week 12 ]
    Clinical response per partial adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1.

  4. Percentage of participants with clinical remission per Full Mayo score in participants with a Full Mayo score of 6 to 12 at Baseline [ Time Frame: At Week 8 ]
    Clinical Remission per full Mayo score is defined as full Mayo score <=2 with no subscore > 1.

  5. Percentage of participants with endoscopic remission [ Time Frame: At Week 8 ]
    Endoscopic remission is defined as Mayo endoscopic subscore = 0.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
  • Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
  • History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug).

Exclusion Criteria:

  • Participant having an active, chronic, or recurrent infection that based on Investigator's clinical assessment makes the participant an unsuitable candidate for the study.
  • Participant having any malignancy except for successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
  • Participant with history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the screening endoscopy other than completely removed low-grade dysplastic lesions.
  • Laboratory values not meeting the following criteria : Serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2* upper limit of normal (ULN); Total white blood cell (WBC) count >= 3.0*109/L.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695185


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, California
Orange County Institute of Gastroenterology and Endoscopy /ID# 207405 Not yet recruiting
Mission Viejo, California, United States, 92691-6306
United States, Pennsylvania
Penn Presbyterian Medical Center /ID# 206826 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104-2640
United States, Tennessee
Vanderbilt Univ Med Ctr /ID# 204670 Not yet recruiting
Nashville, Tennessee, United States, 37232-0011
Canada, Ontario
Mount Sinai Hosp.-Toronto /ID# 206180 Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal General Hospital /ID# 204732 Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Italy
Complesso integrato Columbus /ID# 204549 Not yet recruiting
Rome, Italy, 00168
United Kingdom
Queen Elizabeth University Hos /ID# 206574 Not yet recruiting
Glasgow, Glasgow City, United Kingdom, G51 4TF
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03695185     History of Changes
Other Study ID Numbers: M15-722
2018-000930-37 ( EudraCT Number )
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Ulcerative Colitis (UC)
ABBV-323

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases