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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002512-32 | EudraCT Number |
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This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A. The study will consist of a repeat dose escalation in HVs, in participants with UC, and in participants with CD across multiple sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | Experimental | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
|
| Ulcerative Colitis | Experimental | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
|
| Crohn's Disease | Experimental | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo to UTTR1147A administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | Up to Day 134 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of UTTR1147A After the First and Last Dose | Up to Day 134 | |
| Minimum (Trough) Serum Concentrations (Ctrough) of UTTR1147A Prior to the Second and Last Dose | Up to Day 134 |
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Inclusion Criteria:
General inclusion criteria:
For HVs Only:
For Participants with UC or CD:
Exclusion Criteria:
General exclusion criteria:
For HVs Only:
For Participants with UC or CD:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany | |||
| Royal Victoria Infirmary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36732049 | Derived | Wagner F, Mansfield JC, Lekkerkerker AN, Wang Y, Keir M, Dash A, Butcher B, Harder B, Orozco LD, Mar JS, Chen H, Rothenberg ME. Dose escalation randomised study of efmarodocokin alfa in healthy volunteers and patients with ulcerative colitis. Gut. 2023 Aug;72(8):1451-1461. doi: 10.1136/gutjnl-2022-328387. Epub 2023 Feb 2. | |
| 31792136 |
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| UTTR1147A | Drug | Escalating doses of intravenously administered UTTR1147A |
|
|
| Total Serum Clearance (CL) of UTTR1147A | Up to Day 134 |
| Volume of Distribution (V) of UTTR1147A | Up to Day 134 |
| Area Under the Concentration vs. Time Curve (AUC) Within a Dose Interval (AUCtau) After the Final Dose of UTTR1147A | Up to Day 134 |
| Elimination Half-Life (t1/2) of UTTR1147A | Up to Day 134 |
| Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) in Serum | Up to Day 134 |
| Newcastle upon Tyne |
| NE1 4LP |
| United Kingdom |
| Powell N, Pantazi E, Pavlidis P, Tsakmaki A, Li K, Yang F, Parker A, Pin C, Cozzetto D, Minns D, Stolarczyk E, Saveljeva S, Mohamed R, Lavender P, Afzali B, Digby-Bell J, Tjir-Li T, Kaser A, Friedman J, MacDonald TT, Bewick GA, Lord GM. Interleukin-22 orchestrates a pathological endoplasmic reticulum stress response transcriptional programme in colonic epithelial cells. Gut. 2020 Mar;69(3):578-590. doi: 10.1136/gutjnl-2019-318483. Epub 2019 Dec 2. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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