Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Signed informed consent. 2. Participants of either gender greater than or equal to (>=) 18 years and less than or equal to (<=) 75 years of age. 3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria. 4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment; a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria :
- - High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
- - Presence of >=2 external openings.
- - Associated perianal abscess(es).
- - A patient reported outcomes (PRO-2) score <14 at Screening, AND - A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic mucosa: - If colonoscopy data are not available within 6 months prior to Screening: - A simple endoscopic score for Crohn's Disease (SES-CD) <=6 with absence of rectal ulcers larger than 0.5 cm must be documented in a colonoscopy performed at Screening before randomization.
- - If colonoscopy data are available within 6 months prior to Screening, the following must be documented, otherwise a new colonoscopy (as above) will be mandatory: - The absence of ulcers larger than 0.5 cm in the colonic mucosa AND - the improvement or no worsening in abdominal pain and/or in the diarrhea, sustained for one week or more, since the last colonoscopy was performed in the clinical records until Screening visit.
- - Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
- - TNFalpha antagonists: - Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study.
- - Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study.
- - Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study.
- - Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study.
- - Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study.
Exclusion Criteria:1. Concomitant rectovaginal or rectovesical fistula(s). 2. Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs. 3. Presence of a perianal collection >2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0). 4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large >0.5 cm ulcers in the rectum) that make impossible to follow the surgery procedure manual. 5. Participant with diverting stomas. 6. Active, uncontrolled infection requiring parenteral antibiotics. 7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit. 8. Participants with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:
- - Serum creatinine levels >1.5 times the ULN - Total bilirubin >1.5 ULN - Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) >3 times ULN - Hemoglobin <10.0 g/dL - Platelets <75.0*10^9/L - Albuminemia <3.0 g/dL 9.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Takeda|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Poland, Puerto Rico, Spain, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease. The study will randomize approximately 554 participants.
- - Cx601 eASCs intralesional injection - Placebo - Cx601 placebo-matching eASCs intralesional injection Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS).
Cx601 eASCs 120 million cells (5 million cells per milliliter [mL]) will be administered once by intralesional injection.
Placebo Comparator: Placebo
CX601 placebo-matching eASCs cells will be administered once by intralesional administration.
Drug: - Cx601
Cx601 eASCs intralesional injection.
Other: - Placebo
Cx601 placebo-matching eASCs intralesional injection.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.