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

Takeda

Status and phase: Completed; Phase 3

Conditions: Complex Perianal Fistula; Crohn's Disease

Treatments: Other: Placebo; Biological: Darvadstrocel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04075825

Darvadstrocel-3003

2019-000333-39 (EudraCT Number)

Details and patient eligibility

About

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Full description

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have complex perianal fistula in CD. 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 study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Treatment:

Other: Placebo

Darvadstrocel

Experimental group

Description:

Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Treatment:

Biological: Darvadstrocel