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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000333-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Darvadstrocel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
| 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. | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94115 | United States | ||
| Cedar-Sinai Medical Center |
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| Label | URL |
|---|---|
| To obtain more information about this study, click this link. | View source |
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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.
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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.
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 took part in the study at various investigative sites globally from 05 November 2019 to 02 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. |
| FG001 | Darvadstrocel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2022 | Apr 2, 2025 |
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| Darvadstrocel | Biological | 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. |
|
|
| Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
| 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. | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) |
| 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. | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
| 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. | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
| Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 | Percentages were rounded off to the nearest second decimal place. | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
| 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. | 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) |
| 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. | 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) |
| West Hollywood |
| California |
| 90048 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Cleveland Clinic Florida | Fort Lauderdale | Florida | 33331 | United States |
| University of Miami Hospital | Miami | Florida | 33136 | United States |
| USF Health South Tampa Center for Advanced Healthcare | Tampa | Florida | 33606 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| Indiana University - Colon and Rectal | Indianapolis | Indiana | 46237 | United States |
| University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21205 | United States |
| Massachussetts General Hospital - Gastroenterology | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery | Rochester | Minnesota | 55905 | United States |
| Dartmouth Hitchcock Medical Center - Cancer Center | Lebanon | New Hampshire | 03576 | United States |
| Morristown Medical Center - Gastroenterology | Morristown | New Jersey | 07960 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Penn State Hershey Medical Center - Surgery | Hershey | Pennsylvania | 17033 | United States |
| Brown Surgical Associates,Inc. | Providence | Rhode Island | 02904 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Virginia Mason Medical Center - Gastroenterology | Seattle | Washington | 98101 | United States |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| GZA Sint-Vincentius | Antwerp | 2018 | Belgium |
| NH Hospital a.s. | Hořovice | 268 31 | Czechia |
| FN Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| CHRU de Brabois Hopitaux de Brabois | Vandœuvre-lès-Nancy | Nancy | 54511 | France |
| CHRU de Lille - Hopital Claude Huriez - Gastroenterologie | Lille | Nord | 59037 | France |
| CHU de Clermont-Ferrand - Estaing | Clermont-Ferrand | 63003 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti | Rennes | 35033 | France |
| Paris St. Joseph Hospital | Paris | Île-de-France Region | 75014 | France |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar | Szeged | Csongrád megye | 6720 | Hungary |
| MH Egeszsegugyi Kozpont | Budapest | Pest County | 1062 | Hungary |
| Semmelweis Egyetem Altalanos Orvostudomanyi Kar | Budapest | 1088 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika | Debrecen | H-4032 | Hungary |
| Rabin Medical Center, Beilinson Hospital -Gastroenterology | Petah Tikva | Central District | 4941492 | Israel |
| Hadassah Medical Organization, Hadassah Medical Center, Ein- | Jerusalem | Jerusalem | 9112001 | Israel |
| Rambam Medical Centre | Haifa | 31096 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| AOU Policlinico di Modena - Gastroenterologia | Modena | 41124 | Italy |
| Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| PU A. Gemelli, Universita Cattolica del Sacro Cuore | Roma | 00168 | Italy |
| Centrum Medyczne Melita Medical | Wroclaw | Lower Silesian Voivodeship | 50-449 | Poland |
| Wielospecjalistyczny Szpital Medicover | Warsaw | 02-972 | Poland |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| H.U. G.Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Parc Tauli Hospital Universitari | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | 28942 | Spain |
| Hospital Del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic De Barcelona | Barcelona | 08036 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| C.H.U. de Pontevedra | Pontevedra | 36071 | Spain |
| H.U.V. del Rocio | Seville | 21005 | Spain |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants enrolled in the long-term extension (LTE) study, according to the actual treatment they received in the ADMIRE-CD II study.
Week 52 of ADMIRE-CD II is the Baseline (Week 0) for this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Count of Participants | Participants | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
|
|
| |||||||||||||||||||||||||||||
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Count of Participants | Participants | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
| |||||||||||||||||||||||||||||||
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Count of Participants | Participants | Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II) |
| |||||||||||||||||||||||||||||||
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) |
|
| |||||||||||||||||||||||||||||
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Number | 95% Confidence Interval | percentage of participants | At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively) |
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
| ||||||||||||||||||||||||||||||
| 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. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156 | Percentages were rounded off to the nearest second decimal place. | Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 104 of this study (Week 156 in relation to ADMIRE-CD II) |
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
Up to 104 weeks in this study (From Week 52 to Week 156 in relation to ADMIRE-CD II)
Safety Analysis Set included all participants enrolled in the LTE study, according to the actual treatment they received in the ADMIRE-CD II study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 74 | 14 | 74 | 11 | 74 |
| EG001 | 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. | 0 | 76 | 11 | 76 | 14 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anorectal disorder | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fistula discharge | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2023 | Apr 2, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Units |
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| Counts |
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| Participants |
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| Participants |
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| Participants |
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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. |
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| Units | Counts |
|---|---|
| Participants |
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