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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 : Recruiting
First Posted : October 4, 2018
Last Update Posted : November 11, 2019
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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : May 16, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABBV-323
Participants administered with ABBV-323 dose A IV at Week 0 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).




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*10^9/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
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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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: November 11, 2019
Last Verified: November 2019
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.htm

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