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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Placebo is administered intravenously and subcutaneously.
- Percentage of participants with endoscopic improvement [ Time Frame: At Week 8 ]Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 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.
- 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.
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
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|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|
|Mount Sinai Hosp.-Toronto /ID# 206180||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Montreal General Hospital /ID# 204732||Not yet recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Complesso integrato Columbus /ID# 204549||Not yet recruiting|
|Rome, Italy, 00168|
|Queen Elizabeth University Hos /ID# 206574||Not yet recruiting|
|Glasgow, Glasgow City, United Kingdom, G51 4TF|
|Study Director:||AbbVie Inc.||AbbVie|