Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03831438|
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 20, 2019
|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 :||September 30, 2019|
|Estimated Study Completion Date :||October 15, 2019|
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
|Contact: Sandra Sinclair, MHA/ED, RNemail@example.com|
|Contact: Jonathan Delara||512-589-2114|
|United States, New York|
|Hospital of Special Surgery||Recruiting|
|New York, New York, United States, 10035|
|Contact: Eileen McCullagh, RN 212-774-7381 McCullaghE@HSS.EDU|
|Principal Investigator: Spira F Robert, MD|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Christina Morse firstname.lastname@example.org|
|Principal Investigator: Robert Lafyatis, MD|
|Study Chair:||Robert Lafyatis, MD||University of Pittsburgh Medical Center|