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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075825
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

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).

Condition or disease Intervention/treatment Phase
Crohn's Disease Complex Perianal Fistula Biological: Darvadstrocel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Percentage of Participants With New Anal Abscess in Treated Fistula [ Time Frame: Week 104 ]
  6. 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.

  7. 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.



Information from the National Library of Medicine

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

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.


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): NCT04075825


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medinfoUS@takeda.com

Locations
Show Show 66 study locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Medical Director Millennium Pharmaceuticals, Inc.
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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04075825    
Other Study ID Numbers: Darvadstrocel-3003
2019-000333-39 ( EudraCT Number )
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Rectal Diseases
Rectal Fistula
Fistula
Gastroenteritis
Intestinal Fistula
Digestive System Fistula