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This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.
The purpose of this platform study is to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) to evaluate multiple oral or parenteral experimental therapies for moderately to severely active Crohn's Disease or Ulcerative Colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Specific Appendix- Crohn's Disease | Experimental | Participants will receive MT-501 Tablets |
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| Intervention Specific Appendix- Ulcerative Colitis | Experimental | Participants will receive MT-501Tablets |
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| Intervention Specific Appendix- Crohn's Disease with Standard of Care | Experimental | Participants will receive multiple intravenous doses of MT-201 with standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-501 | Drug | MT-501 |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values | Up to 13 weeks | |
| Assess the Proportion of Participants with Endoscopic Response (CD) | Endoscopic response as assessed by SES-CD score. | 13 weeks |
| Assess the Proportion of Participants Endoscopic Improvement (UC) | Endoscopic improvement as assessed by MES. | 12 weeks |
| Assess the Proportion of Participants with Clinical Remission (CD) | Clinical remission as assessed by CDAI score. | 13 weeks |
| Assess the Proportion of Participants with Clinical Remission (UC) | Clinical remission as assessed by endoscopy, rectal bleeding and stool frequency. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Proportion of Participants with Clinical Remission (CD) | CD: Clinical remission as assessed by CDAI score. | 13 weeks |
| Assess the Proportion of Participants with Clinical Remission (UC) |
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Inclusion Criteria-Crohn's Disease:
Inclusion Criteria-Ulcerative Colitis:
Exclusion Criteria-Crohn's Disease:
Exclusion Criteria-Ulcerative Colitis:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ASCEND-IBD Trial Center | Contact | 844-206-4980 | clinicaltrials@miradortx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mirador Therapeutics Selected Site | Recruiting | Birmingham | Alabama | 35235 | United States |
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Prospective Observer-Blinded Endpoint
| MT-201 | Drug | MT-201 |
|
Clinical remission as assessed by endoscopy, rectal bleeding, and stool frequency.
| 12 weeks |
| Assess the Proportion of Participants with Symptomatic Remission (CD and UC) | Symptomatic remission as assessed by patient reported outcomes. | Up to 13 weeks |
| Assess the Proportion of Participants with Clinical Response (CD) | CD: Clinical response as assessed by CDAI score. | 13 weeks |
| Assess the Proportion of Participants with Clinical Response (UC) | UC: Clinical response as assessed by MMCS. | 12 weeks |
| Assess the Proportion of Participants with Endoscopic and Clinical Response (CD Only) | Endoscopy as assessed by SES-CD and clinical response as assessed by CDAI score. | 13 weeks |
| Assess the Proportion of Participants with Histologic Response (UC Only) | Histologic response as assessed by the RHI. | 12 weeks |
| Assess the Proportion of Participants with Histologic Remission (UC only) | Histologic remission as assessed by the RHI. | 12 weeks |
| Assess the Proportion of Participants with Histologic-Endoscopic Mucosal Improvement (UC only) | Histologic-endoscopic mucosal improvement as assessed by the Geboes score and MES. | 12 weeks |
| Characterize the Change in Endoscopy Score (CD) | CD: Endoscopy score as assessed by SES-CD. | 13 weeks |
| Characterize the Change in Endoscopy Score (UC) | Endoscopy score as assessed by MES. | 12 weeks |
| Characterize the Change in Histology Score (CD) | Histology as assessed by GHAS and RHI. | 13 weeks |
| Characterize the Change in Histology Score (UC) | Histology as assessed by Geobes, RHI and NHI | 12 weeks |
| Asses the Pharmacokinetics (PK) (e.g., Trough Concentration [Ctrough]) of Investigational Drug | Up to 13 weeks |
| Assess immunogenicity | 13 weeks |
| Mirador Therapeutics Selected Site | Recruiting | Scottsdale | Arizona | 85258 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Sun City | Arizona | 85351 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Little Rock | Arkansas | 72211 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Colorado Springs | Colorado | 80921 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Littleton | Colorado | 80120 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Miami | Florida | 33134 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Miami | Florida | 33165 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Miami | Florida | 33176 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Orlando | Florida | 32825 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Palmetto Bay | Florida | 33176 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Pensacola | Florida | 32504 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Atlanta | Georgia | 30342 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Snellville | Georgia | 30078 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Glenview | Illinois | 60026 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Gurnee | Illinois | 60031 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Lafayette | Louisiana | 70503 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Marrero | Louisiana | 70072 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Shreveport | Louisiana | 71105 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Ypsilanti | Michigan | 48197 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Bridgeton | Missouri | 63044 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Kansas City | Missouri | 64114 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Liberty | Missouri | 64068 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Las Vegas | Nevada | 89128 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | New York | New York | 10016 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Rochester | New York | 14618 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | High Point | North Carolina | 27262 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Raleigh | North Carolina | 27612 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Liberty Township | Ohio | 45044 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Providence | Rhode Island | 02904 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Greenville | South Carolina | 29607 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Cordova | Tennessee | 38018 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Dallas | Texas | 75230 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Garland | Texas | 75044 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Georgetown | Texas | 78628 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Houston | Texas | 77090 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Lubbock | Texas | 79424 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Southlake | Texas | 76092 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Tyler | Texas | 75701 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Webster | Texas | 77598 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Bellevue | Washington | 98004 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Silverdale | Washington | 98383 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Tacoma | Washington | 98405 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| Mirador Therapeutics Selected Site | Recruiting | Toronto | Canada |
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| Mirador Therapeutics Selected Site | Recruiting | Kutaisi | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Marneuli | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 0102 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 0144 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 0159 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 0178 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 0180 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Tbilisi | 4600 | Georgia |
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| Mirador Therapeutics Selected Site | Recruiting | Chisinau | Moldova |
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| Mirador Therapeutics Selected Site | Recruiting | Chisinau | Moldova |
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| Mirador Therapeutics Selected Site | Recruiting | Ivano-Frankivsk | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Kyiv | 02002 | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Kyiv | 02091 | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Kyiv | 03037 | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Kyiv | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Lutsk | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Lviv | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Poltava | Ukraine |
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| Mirador Therapeutics Selected Site | Recruiting | Vinnytsia | Ukraine |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| C460839 | adecatumumab |
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