Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT03831438|
Recruitment Status : Active, not recruiting
First Posted : February 5, 2019
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Scleroderma, Diffuse||Drug: AVID200||Phase 1|
The trial is designed to evaluate the safety and tolerability of sequential escalating doses of AVID200 (study drug), in order delineate a potential effective range of tolerated doses to be further evaluated in Phase 2.
Patients will be treated and followed on an outpatient basis throughout the trial, unless hospitalization is required for other reasons, or to assure patient safety. The choice of doses for further Phase 2 study will be based on clinical and laboratory data obtained during this trial, including safety, PK, and preliminary anti-fibrotic activity.
Upon completion of Cycle 1, and provided re-treatment criteria are met, patients may receive up to 2 additional cycles of study drug unless a criterion for treatment discontinuation has been met.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, uncontrolled, non-randomized study, escalating doses of study drug in sequential patient cohorts|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Open-Label Study to Determine the Safety and Tolerability of AVID200: A Transforming Growth Factor β (TGFβ) Inhibitor, in Patients With Diffuse Cutaneous Systemic Sclerosis|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
Sequential escalating doses of AVID200 when administered once every 2 weeks (Q2W) by 1-hour intravenous (IV) infusion to patient cohorts with diffuse cutaneous systemic sclerosis (dcSSc).
Each 2-week dosing period equals 1 cycle; patients may receive up to 3 cycles of AVID200 (i.e., dosing on D1, 15, and 29 of overall 6 week treatment period).
Intravenous infusion of AVID200 Q2 weeks for 3 doses
Other Name: AVID200 DP
- Primary Outcome: Incidence of treatment related adverse events [ Time Frame: 10 Months ]Incidence of treatment related adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831438
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|Hospital of Special Surgery|
|New York, New York, United States, 10035|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||Robert Lafyatis, MD||University of Pittsburgh Medical Center|