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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 10, 2018

Estimated Primary Completion Date

December 18, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of participants with endoscopic improvement[ Time Frame: At Week 8 ]

Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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).
Drug: Placebo
Placebo is administered intravenously and subcutaneously.

Study Arms

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
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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 16, 2023

Estimated Primary Completion Date

December 18, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada|Italy|United Kingdom|United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

AbbVie

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: AbbVie Inc. AbbVie

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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