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Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

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ClinicalTrials.gov Identifier: NCT04075825
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Tracking Information
First Submitted Date  ICMJE August 22, 2019
First Posted Date  ICMJE September 3, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE November 4, 2019
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 156 after investigational medicinal product (IMP) administration ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 156 after IMP administration ]
    An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
  • Number of Participants With Specific Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 156 after IMP administration ]
    AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol specified immunogenicity/alloimmune reactions, tumorgenicity and ectopic tissue formation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [ Time Frame: Baseline and Weeks 104 and 156 ]
    Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.
  • Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [ Time Frame: Baseline and Weeks 104 and 156 ]
    Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.
  • Percentage of Participants With Relapse [ Time Frame: Week 52 up to Week 104 ]
    Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed in participants who were in clinical remission at Week 52. Or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment.
  • Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) [ Time Frame: Baseline and Week 156 ]
    Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline (ie, screening visit), despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment.
  • Percentage of Participants With New Anal Abscess in Treated Fistula [ Time Frame: Week 104 ]
  • Change from Baseline in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [ Time Frame: Weeks 104 and 156 ]
    The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, discharge will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
  • Change from Baseline in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) [ Time Frame: Weeks 104 and 156 ]
    The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, pain will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula
Official Title  ICMJE A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study
Brief Summary The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
Detailed Description

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have Crohn's disease (CD) and complex perianal fistula. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.

The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 104 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Crohn's Disease
  • Complex Perianal Fistula
Intervention  ICMJE Biological: Darvadstrocel
Allogenic eASCs 5 million cells/ml - suspension for injection Cx601 received in previous ADMIRE-CD II study. No drug administration in this study.
Other Name: Cx601
Study Arms  ICMJE Experimental: Darvadstrocel
Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally or darvadstrocel matching placebo previously in the ADMIRE-CD II study will be observed for efficacy and safety. No drug administration in this study.
Intervention: Biological: Darvadstrocel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2024
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria:

1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Hungary,   Israel,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075825
Other Study ID Numbers  ICMJE Darvadstrocel-3003
2019-000333-39 ( EudraCT Number )
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/
Responsible Party Takeda ( Millennium Pharmaceuticals, Inc. )
Study Sponsor  ICMJE Millennium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Millennium Pharmaceuticals, Inc.
PRS Account Takeda
Verification Date March 2021

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