The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Public ClinicalTrials.gov record NCT04985968. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Study identification
- NCT ID
- NCT04985968
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- InDex Pharmaceuticals
- Industry
- Enrollment
- 171 participants
Conditions and interventions
Conditions
Interventions
- Cobitolimod 250 mg Drug
- Cobitolimod 500 mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 23, 2021
- Primary completion
- Dec 19, 2023
- Completion
- Dec 19, 2023
- Last update posted
- Dec 26, 2023
2021 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 10
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Amicis Research Center | Granada Hills | California | 91344 | — |
| Allameh Medical Corporation | Mission Viejo | California | 92691 | — |
| Prospective Research Innovations Inc. | Rancho Cucamonga | California | 91730 | — |
| Valiance Clinical Research | Tarzana | California | 91356 | — |
| RecioMed Clinical Research Network, Inc. | Boynton Beach | Florida | 33472 | — |
| MB & V Medical Research | Doral | Florida | 33172 | — |
| A+ Research, Inc. | Miami | Florida | 33012 | — |
| SouthCoast Research Center, Inc | Miami | Florida | 33136 | — |
| I.V.A.M. Clinical & Investigational Center LLC | Miami | Florida | 33144 | — |
| D&H National Research Centers, Inc. | Miami | Florida | 33155 | — |
| Medical Professionals Clinical Research Center | Miami | Florida | 33165 | — |
| Gastroenterology Group Of Naples | Naples | Florida | 34102 | — |
| Alliance Clinical Research - Gastroenterology | Tampa | Florida | 33615 | — |
| Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | — |
| Clinical Research Institute of Michigan | Troy | Michigan | 48098 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| Carolina Digestive Health Associates, PA | Charlotte | North Carolina | 28209 | — |
| Carolina Research | Greenville | North Carolina | 27834 | — |
| Peters Medical Research | High Point | North Carolina | 27262 | — |
| Dayton Gastroenterology | Beavercreek | Ohio | 45440 | — |
| Digestive Health Associates of Texas, PA | Carrollton | Texas | 75019 | — |
| Clinical Research Solution: Digestive Health Associates | Houston | Texas | 77024 | — |
| Baylor College of Medicine - Gastroeneterology | Houston | Texas | 77030 | — |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | — |
| Wisconsin Center For Advanced Research | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 178 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04985968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2023 · Synced May 13, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04985968 live on ClinicalTrials.gov.