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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000333-39-CZ

Enrollment

150

Registered

2019-09-03

Start date

2019-10-15

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal fistulising Crohn´s disease MedDRA version: 20.0 Level: PT Classification code 10002156 Term: Anal fistula System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Alofisel Product Name: Cx601 Product Code: Cx601 Pharmaceutical Form: Suspension for injection INN or Proposed INN: DARVADSTROCEL Current Sponsor code: Allogenic eASCs Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject eligibility is determined according to the following criteria before entry into the study: 1. In the opinion of the investigator, the subject is capable of understanding and complying withprotocol requirements. 2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written ICF and any required privacy authorization before the initiation of any study procedures. 3. The subject has participated in and completed the ADMIRE-CD II study (ie, did not discontinue). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: Subjects will not be eligible for inclusion in the study if: 1. It has been more than 3 months since the subject completed the ADMIRE-CD II study. 2. Subjects are currently receiving, have received any investigational drug in the last 3 months before the inclusion in the study, or are planning to receive any investigational drug during the duration of this LTE study, except for prior participation in the ADMIRE-CD II study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety of a single dose of darvadstrocel in subjects with CD and complex perianal fistula by evaluation of AEs, serious adverse events (SAEs), and adverse events of special interest (AESIs). ;Secondary Objective: To evaluate the long-term efficacy of a single dose of darvadstrocel for the treatment of complex perianal fistula(s) in subjects with CD. ;Primary end point(s): - AEs. - SAEs. - Specific AESIs: – Immunogenicity/alloimmune reactions. – Tumorgenicity. – Ectopic tissue formation. ;Timepoint(s) of evaluation of this end point: Examinations/assessments at week 0, 52, 104. Telephone calls every 3 months.	—

Measure

Time frame

Main Objective: To evaluate the long-term safety of a single dose of darvadstrocel in subjects with CD and complex perianal fistula by evaluation of AEs, serious adverse events (SAEs), and adverse events of special interest (AESIs). ;Secondary Objective: To evaluate the long-term efficacy of a single dose of darvadstrocel for the treatment of complex perianal fistula(s) in subjects with CD. ;Primary end point(s): - AEs. - SAEs. - Specific AESIs: – Immunogenicity/alloimmune reactions. – Tumorgenicity. – Ectopic tissue formation. ;Timepoint(s) of evaluation of this end point: Examinations/assessments at week 0, 52, 104. Telephone calls every 3 months.

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of subjects who achieve clinical remission at Week 104 and Week 156 after IMP administration. – Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression. - Proportion of subjects who achieve clinical response at Week 104 and Week 156 after IMP administration. – 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. Proportion of subjects with a relapse where a relapse is defined as: – Reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed in subjects 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. - Proportion of subjects who achieve combined remission at Week 156 after IMP administration. –- Combined remission of complex perianal fistula(s), 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. - Proportion of subjects with new anal abscess in treated fistula. - Change from baseline to Week 104 and Week 156 after IMP administration in in scores of discharge and pain items of Perianal Disease Activity Index (PDAI) score. ;Timepoint(s) of evaluation of this end point: Examinations/assessments at week 0, 52, 104. Telephone calls every 3 months.	—

Measure

Time frame

Secondary end point(s): Proportion of subjects who achieve clinical remission at Week 104 and Week 156 after IMP administration. – Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression. - Proportion of subjects who achieve clinical response at Week 104 and Week 156 after IMP administration. – 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. Proportion of subjects with a relapse where a relapse is defined as: – Reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed in subjects 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. - Proportion of subjects who achieve combined remission at Week 156 after IMP administration. –- Combined remission of complex perianal fistula(s), 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. - Proportion of subjects with new anal abscess in treated fistula. - Change from baseline to Week 104 and Week 156 after IMP administration in in scores of discharge and pain items of Perianal Disease Activity Index (PDAI) score. ;Timepoint(s) of evaluation of this end point: Examinations/assessments at week 0, 52, 104. Telephone calls every 3 months.

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Countries

Belgium, Canada, Czechia, Czech Republic, France, Germany, Hungary, Israel, Italy, Poland, Spain, United Kingdom, United States

Contacts

Public ContactClinical Operations

Takeda Development Center Americas, Inc

inmaculada.gilaberte@takeda.com+34918049264

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026