Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)

Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.

Study Overview

• Status: Terminated
• Conditions: Chronic Lymphocytic Leukemia
• Intervention / Treatment: Biological: Ublituximab; Drug: TGR-1202; Biological: Obinutuzumab; Drug: Chlorambucil

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel
    • TG Therapeutics Investigational Trial Site
  • Be'er Sheva, Israel
    • TG Therapeutics Investigational Trial Site
  • Haifa, Israel
    • TG Therapeutics Investigational Trial Site
  • Jerusalem, Israel
    • TG Therapeutics Investigational Trial Site
  • Nahariya, Israel
    • TG Therapeutics Investigational Trial Site
  • Petah tikva, Israel
    • TG Therapeutics Investigational Trial Site
  • Tel Aviv, Israel
    • TG Therapeutics Investigational Trial Site
• Italy
  • Bologna, Italy
    • TG Therapeutics Investigational Trial Site
  • Ferrara, Italy
    • TG Therapeutics Investigational Trial Site
  • Milan, Italy
    • TG Therapeutics Investigational Trial Site
  • Rome, Italy
    • TG Therapeutics Investigational Trial Site
  • Torino, Italy
    • TG Therapeutics Investigational Trial Site
• Poland
  • Chorzów, Poland
    • TG Therapeutics Investigational Trial Site
  • Gdynia, Poland
    • TG Therapeutics Investigational Trial Site
  • Krakow, Poland
    • TG Therapeutics Investigational Trial Site
  • Lublin, Poland
    • TG Therapeutics Investigational Trial Site
  • Słupsk, Poland
    • TG Therapeutics Investigational Trial Site
  • Warszawa, Poland
    • TG Therapeutics Investigational Trial Site
  • Wroclaw, Poland
    • TG Therapeutics Investigational Trial Site
  • Łódź, Poland
    • TG Therapeutics Investigational Trial Site
• Russian Federation
  • Krasnozatonskiy, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Moscow, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Perm, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Petrozavodsk, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Rodionova, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Saint Petersburg, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Smolensk, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Tula, Russian Federation
    • TG Therapeutics Investigational Trial Site
  • Yaroslavl, Russian Federation
    • TG Therapeutics Investigational Trial Site
• Spain
  • Barcelona, Spain
    • TG Therapeutics Investigational Trial Site
  • Madrid, Spain
    • TG Therapeutics Investigational Trial Site
  • Valencia, Spain
    • TG Therapeutics Investigational Trial Site
• United Kingdom
  • Cambridge, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Cumbria, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Dudley West, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • London, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Northbrook, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Northumbria, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Norwich, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Peterborough, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Southampton, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • St. James, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Sunderland, United Kingdom
    • TG Therapeutics Investigational Trial Site
  • Wolverhampton, United Kingdom
    • TG Therapeutics Investigational Trial Site
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • TG Therapeutics Investigational Trial Site
    • Mobile, Alabama, United States, 36604
      • TG Therapeutics Investigational Trial Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • TG Therapeutics Investigational Trial Site
    • Phoenix, Arizona, United States, 85016
      • TG Therapeutics Investigational Trial Site
    • Tucson, Arizona, United States, 85711
      • TG Therapeutics Investigational Trial Site
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • TG Therapeutics Investigational Trial Site
  • California
    • Concord, California, United States, 94520
      • TG Therapeutics Investigational Trial Site
    • Duarte, California, United States, 91010
      • TG Therapeutics Investigational Trial Site
    • Greenbrae, California, United States, 94904
      • TG Therapeutics Investigational Trial Site
    • Pismo Beach, California, United States, 93449
      • TG Therapeutics Investigational Trial Site
    • Pleasanton, California, United States, 94588
      • TG Therapeutics Investigational Trial Site
    • San Diego, California, United States, 92120
      • TG Therapeutics Investigational Trial Site
    • Santa Barbara, California, United States, 93105
      • TG Therapeutics Investigational Trial Site
    • Whittier, California, United States, 90603
      • TG Therapeutics Investigational Trial Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • TG Therapeutics Investigational Trial Site
    • Denver, Colorado, United States, 80218
      • TG Therapeutics Investigational Trial Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • TG Therapeutics Investigational Trial Site
    • New Haven, Connecticut, United States, 06519
      • TG Therapeutics Investigational Trial Site
    • Stamford, Connecticut, United States, 06904
      • TG Therapeutics Investigational Trial Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • TG Therapeutics Investigational Trial Site
  • Florida
    • Boca Raton, Florida, United States, 33486
      • TG Therapeutics Investigational Trial Site
    • Fort Myers, Florida, United States, 33916
      • TG Therapeutics Investigational Trial Site
    • Jacksonville, Florida, United States, 32204
      • TG Therapeutics Investigational Trial Site
    • Jacksonville, Florida, United States, 32256
      • TG Therapeutics Investigational Trial Site
    • Ocala, Florida, United States, 34471
      • TG Therapeutics Investigational Trial Site
    • Pensacola, Florida, United States, 32504
      • TG Therapeutics Investigational Trial Site
    • Saint Petersburg, Florida, United States, 33705
      • TG Therapeutics Investigational Trial Site
    • Tallahassee, Florida, United States, 32308
      • TG Therapeutics Investigational Trial Site
    • Tampa, Florida, United States, 33612
      • TG Therapeutics Investigational Trial Site
    • West Palm Beach, Florida, United States, 33407
      • TG Therapeutics Investigational Trial Site
  • Georgia
    • Albany, Georgia, United States, 31701
      • TG Therapeutics Investigational Trial Site
    • Macon, Georgia, United States, 31201
      • TG Therapeutics Investigational Trial Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • TG Therapeutics Investigational Trial Site
    • Decatur, Illinois, United States, 62526
      • TG Therapeutics Investigational Trial Site
    • Maywood, Illinois, United States, 60153
      • TG Therapeutics Investigational Trial Site
    • Niles, Illinois, United States, 60714
      • TG Therapeutics Investigational Trial Site
    • Peoria, Illinois, United States, 61615
      • TG Therapeutics Investigational Trial Site
    • Swansea, Illinois, United States
      • TG Therapeutics Investigational Trial Site
    • Urbana, Illinois, United States, 61801
      • TG Therapeutics Investigational Trial Site
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • TG Therapeutics Investigational Trial Site
    • Indianapolis, Indiana, United States, 46237
      • TG Therapeutics Investigational Trial Site
  • Iowa
    • Ames, Iowa, United States, 50010
      • TG Therapeutics Investigational Trial Site
    • Cedar Rapids, Iowa, United States, 52403
      • TG Therapeutics Investigational Trial Site
  • Kansas
    • Kansas City, Kansas, United States, 64132
      • TG Therapeutics Investigational Trial Site
    • Westwood, Kansas, United States, 66210
      • TG Therapeutics Investigational Trial Site
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • TG Therapeutics Investigational Trial Site
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • TG Therapeutics Investigational Trial Site
    • Baltimore, Maryland, United States, 21215
      • TG Therapeutics Investigational Trial Site
    • Bethesda, Maryland, United States, 20817
      • TG Therapeutics Investigational Trial Site
    • Columbia, Maryland, United States, 21044
      • TG Therapeutics Investigational Trial Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • TG Therapeutics Investigational Trial Site
    • Worcester, Massachusetts, United States, 01608
      • TG Therapeutics Investigational Trial Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • TG Therapeutics Investigational Trial Site
    • Detroit, Michigan, United States, 48202
      • TG Therapeutics Investigational Trial Site
    • Jackson, Michigan, United States, 49201
      • TG Therapeutics Investigational Trial Site
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • TG Therapeutics Investigational Trial Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • TG Therapeutics Investigational Trial Site
    • Kansas City, Missouri, United States
      • TG Therapeutics Investigational Trial Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • TG Therapeutics Investigational Trial Site
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • TG Therapeutics Investigational Trial Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • TG Therapeutics Investigational Trial Site
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • TG Therapeutics Investigational Trial Site
    • Somerville, New Jersey, United States, 00876
      • TG Therapeutics Investigational Trial Site
  • New York
    • East Setauket, New York, United States, 11733
      • TG Therapeutics Investigational Trial Site
    • Glens Falls, New York, United States, 12801
      • TG Therapeutics Investigational Trial Site
    • Syracuse, New York, United States, 13210
      • TG Therapeutics Investigational Trial Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • TG Therapeutics Investigational Trial Site
    • Durham, North Carolina, United States, 27710
      • TG Therapeutics Investigational Trial Site
    • Durham, North Carolina, United States
      • TG Therapeutics Investigational Trial Site
    • Hickory, North Carolina, United States, 28602
      • TG Therapeutics Investigational Trial Site
    • Kinston, North Carolina, United States, 28501
      • TG Therapeutics Investigational Trial Site
    • Raleigh, North Carolina, United States, 27607
      • TG Therapeutics Investigational Trial Site
    • Washington, North Carolina, United States, 27889
      • TG Therapeutics Investigational Trial Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • TG Therapeutics Investigational Trial Site
    • Cincinnati, Ohio, United States, 45236
      • TG Therapeutics Investigational Trial Site
    • Toledo, Ohio, United States, 43623
      • TG Therapeutics Investigational Trial Site
  • Oregon
    • Portland, Oregon, United States, 97227
      • TG Therapeutics Investigational Trial Site
    • Portland, Oregon, United States, 97239
      • TG Therapeutics Investigational Trial Site
    • Springfield, Oregon, United States, 97477
      • TG Therapeutics Investigational Trial Site
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • TG Therapeutics Investigational Trial Site
    • Danville, Pennsylvania, United States, 17822
      • TG Therapeutics Investigational Trial Site
    • Hershey, Pennsylvania, United States, 17033
      • TG Therapeutics Investigational Trial Site
    • Philadelphia, Pennsylvania, United States, 19106
      • TG Therapeutics Investigational Trial Site
    • Pittsburgh, Pennsylvania, United States, 15224
      • TG Therapeutics Investigational Trial Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • TG Therapeutics Investigational Trial Site
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 00286
      • TG Therapeutics Investigational Trial Site
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • TG Therapeutics Investigational Trial Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • TG Therapeutics Investigational Trial Site
    • Watertown, South Dakota, United States, 57201
      • TG Therapeutics Investigational Trial Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • TG Therapeutics Investigational Trial Site
    • Nashville, Tennessee, United States, 37203
      • TG Therapeutics Investigational Trial Site
  • Texas
    • Austin, Texas, United States, 78705
      • TG Therapeutics Investigational Trial Site
    • Bedford, Texas, United States, 76022
      • TG Therapeutics Investigational Trial Site
    • Fort Worth, Texas, United States, 76104
      • TG Therapeutics Investigational Trial Site
    • Houston, Texas, United States, 77030
      • TG Therapeutics Investigational Trial Site
    • San Antonio, Texas, United States, 78229
      • TG Therapeutics Investigational Trial Site
    • San Antonio, Texas, United States, 78217
      • TG Therapeutics Investigational Trial Site
    • Tyler, Texas, United States, 75702
      • TG Therapeutics Investigational Trial Site
  • Utah
    • Ogden, Utah, United States, 84405
      • TG Therapeutics Investigational Trial Site
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • TG Therapeutics Investigational Trial Site
    • Charlottesville, Virginia, United States, 22908
      • TG Therapeutics Investigational Trial Site
    • Fort Belvoir, Virginia, United States, 22060
      • TG Therapeutics Investigational Trial Site
  • Washington
    • Olympia, Washington, United States, 98502
      • TG Therapeutics Investigational Trial Site
    • Seattle, Washington, United States, 98109
      • TG Therapeutics Investigational Trial Site
    • Seattle, Washington, United States, 98104
      • TG Therapeutics Investigational Trial Site
    • Spokane, Washington, United States, 99216
      • TG Therapeutics Investigational Trial Site
    • Vancouver, Washington, United States, 98684
      • TG Therapeutics Investigational Trial Site
    • Yakima, Washington, United States, 98902
      • TG Therapeutics Investigational Trial Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • TG Therapeutics Investigational Trial Site
    • Wauwatosa, Wisconsin, United States, 53226
      • TG Therapeutics Investigational Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
• Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
• Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Ublituximab + Umbralisib; Participants received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Ublituximab; Ublituximab: IV infusion; Drug: TGR-1202; TGR-1202: Oral daily dose
Active Comparator: Arm B: Obinutuzumab + Chlorambucil; Participants received Obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 15 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with Chlorambucil 0.5 milligram per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Obinutuzumab; Obinutuzumab: IV infusion; Other Names: GAZYVA; Drug: Chlorambucil; Chlorambucil: Oral dose; Other Names: Leukeran
Experimental: Arm C: Ublituximab; Participants received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.	Biological: Ublituximab; Ublituximab: IV infusion
Experimental: Arm D: Umbralisib; Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.	Drug: TGR-1202; TGR-1202: Oral daily dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria	PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 centimetres (cm) in the longest diameter (LD) and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 grams per Liter (g/L) decrease from the highest on-study hemoglobin (Hgb).	From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR) Per iwCLL Criteria	ORR=percent of participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR).CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L);Regression of all target nodal masses to ≤1.5cm in LD;Normal spleen,liver size;Regression to normal of all nodal non-target disease and disappearance of all detectable;Non-nodal,non-target disease;Morphologically negative bone marrow;No lymphoid nodules;ANC >1.5x10^9/L,platelets≥100x10^9/L,Hgb≥110 g/L.PR:No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or ≥50% decrease from baseline in sum of products of target nodal lesions;splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;response in any 1: ANC>1.5x10^9/L, platelets>100x10^9/L,Hgb>110g/L or ≥50% increase over baseline in any of these.CRi:for CR except with ANC<1000/µL and/or platelets<100.	Up to 87 months
Complete Response (CR) Rate	The CR rate is defined as the percentage of participants with a best overall response of complete response (CR) or complete response with incomplete marrow recovery (CRi). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/L; Regression of all target nodal masses to ≤1.5 cm in LD; Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC>1.5x10^9/L,platelets≥100x10^9/L,hemoglobin (Hgb)≥110 g/L. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL.	Up to 87 months
Minimal Residual Disease (MRD) Negativity Rate	MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow.	From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months
Duration of Response (DOR)	DOR is defined as the interval from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of definitive disease progression or death from any cause.	From first documentation of response to study treatment till disease progression/death (up to approximately 87 months)
Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related.	From first dose of study treatment up to end of study (up to approximately 87 months)

Collaborators and Investigators

• Sponsor: TG Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2015
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimated): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Alkylating; Alkylating Agents; Obinutuzumab; Chlorambucil
• Other Study ID Numbers: UTX-TGR-304; 2015-005758-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No