Complex Perianal Fistula, Crohn's Disease
Conditions
Keywords
Drug therapy
Brief summary
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.
Detailed 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.
Interventions
OTHERPlacebo
Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.
BIOLOGICALDarvadstrocel
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an 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. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. |
| Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) | TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
| Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) | AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) | 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 of ADMIRE-CD II, 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. Percentages were rounded off to the nearest second decimal place. |
| Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) | Percentages were rounded off to the nearest second decimal place. |
| Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) | Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place. |
| Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) | The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'pain' was used for this outcome measure. 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 of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) | The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'discharge' was used for this outcome measure. 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. |
| Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) | Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place. |
| Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) | Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection \>2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment. Combined remission at Week 52 was defined as clinically assessed closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment. Percentages were rounded off to the nearest second decimal place. |
Countries
Belgium, Czechia, France, Hungary, Israel, Italy, Poland, Spain, United States
Participant flow
Recruitment details
Participants took part in the study at various investigative sites globally from 05 November 2019 to 02 April 2024.
Pre-assignment details
Participants diagnosed with Complex Perianal Fistula in Crohn's Disease (CD) who completed the Week 52 visit in the parent study ADMIRE-CD II (Cx601-0303, NCT03279081) were enrolled. Participants remained in the treatment group (placebo or darvadstrocel) to which they were assigned in ADMIRE-CD II study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants who received darvadstrocel placebo-matching eASCs intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study. | 74 |
| Darvadstrocel 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. | 76 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Participation in New Clinical Trial | 1 | 1 |
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Reason Not Specified | 2 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Darvadstrocel | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 12.04 | 39.8 years STANDARD_DEVIATION 11.69 | 38.9 years STANDARD_DEVIATION 11.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 127 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 14 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) White | 68 Participants | 141 Participants | 73 Participants |
| Sex: Female, Male Female | 35 Participants | 63 Participants | 28 Participants |
| Sex: Female, Male Male | 41 Participants | 87 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 76 |
| other Total, other adverse events | 11 / 74 | 14 / 76 |
| serious Total, serious adverse events | 14 / 74 | 11 / 76 |
Outcome results
Primary
Number of Participants With Specific Adverse Events of Special Interest (AESIs)
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy.
Time frame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Fistula, Abscess | 6 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Hypersensitivity | 3 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Tumorgenicity | 1 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Anaphylactic Reaction | 0 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Ectopic Tissue Formation | 1 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Malignancy | 1 Participants |
| Placebo | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Immunogenicity/Allo-immunoreactions | 3 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Malignancy | 2 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Immunogenicity/Allo-immunoreactions | 7 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Tumorgenicity | 3 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Fistula, Abscess | 7 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Ectopic Tissue Formation | 0 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Hypersensitivity | 3 Participants |
| Darvadstrocel | Number of Participants With Specific Adverse Events of Special Interest (AESIs) | Anaphylactic Reaction | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered an 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. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Time frame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 40 Participants |
| Darvadstrocel | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 43 Participants |
Primary
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 14 Participants |
| Darvadstrocel | Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) | 11 Participants |
Secondary
Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'discharge' was used for this outcome measure. 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.
Time frame: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. Overall number analyzed is the number of participants with data available at ADMIRE-CD II Baseline. Number analyzed is the number of participants with data available for analyses at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | ADMIRE-CD II Baseline Score | 1.53 score on a scale | Standard Deviation 1.072 |
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 52 of this study | -0.67 score on a scale | Standard Deviation 1.178 |
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 104 of this study | -0.67 score on a scale | Standard Deviation 1.279 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | ADMIRE-CD II Baseline Score | 1.25 score on a scale | Standard Deviation 0.893 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 52 of this study | -0.56 score on a scale | Standard Deviation 1.218 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 104 of this study | -0.50 score on a scale | Standard Deviation 1.128 |
Secondary
Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156
The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, only 'pain' was used for this outcome measure. 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.
Time frame: From Baseline of ADMIRE-CD II up to Weeks 52 and 104 of this study (From Baseline up to Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. Overall number analyzed is the number of participants with data available at ADMIRE-CD II Baseline. Number analyzed is the number of participants with data available for analyses at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | ADMIRE-CD II Baseline Score | 1.25 score on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 52 of this study | -0.49 score on a scale | Standard Deviation 1.391 |
| Placebo | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 104 of this study | -0.56 score on a scale | Standard Deviation 1.271 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | ADMIRE-CD II Baseline Score | 1.06 score on a scale | Standard Deviation 0.936 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 52 of this study | -0.54 score on a scale | Standard Deviation 1.01 |
| Darvadstrocel | Change From Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 | Change from ADMIRE-CD II Baseline up to Week 104 of this study | -0.45 score on a scale | Standard Deviation 1.06 |
Secondary
Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.
Time frame: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 52 | 36.49 percentage of participants |
| Placebo | Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 104 | 31.08 percentage of participants |
| Darvadstrocel | Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 52 | 50.00 percentage of participants |
| Darvadstrocel | Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 104 | 43.42 percentage of participants |
Secondary
Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)
Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression. Percentages were rounded off to the nearest second decimal place.
Time frame: At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 52 | 40.54 percentage of participants |
| Placebo | Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 104 | 32.43 percentage of participants |
| Darvadstrocel | Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 52 | 56.58 percentage of participants |
| Darvadstrocel | Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) | Week 104 | 47.37 percentage of participants |
Secondary
Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)
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 of ADMIRE-CD II, 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. Percentages were rounded off to the nearest second decimal place.
Time frame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) | 29.73 percentage of participants |
| Darvadstrocel | Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) | 36.84 percentage of participants |
Secondary
Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156
Percentages were rounded off to the nearest second decimal place.
Time frame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 | 9.62 percentage of participants |
| Darvadstrocel | Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 | 7.02 percentage of participants |
Secondary
Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II
Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection \>2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment. Combined remission at Week 52 was defined as clinically assessed closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) \>2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central MRI assessment. Percentages were rounded off to the nearest second decimal place.
Time frame: At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)
Population: Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. . Overall number analyzed is the number of participants who were in combined remission at Week 52 of ADMIRE-CD II.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II | 54.76 percentage of participants |
| Darvadstrocel | Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II | 42.50 percentage of participants |