Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04799353
• Other study ID #: M19-972
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2021
• Est. completion date: October 11, 2022

Study information

• Verified date: October 2022
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.

Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.

Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks.

Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Condition of generally good health, body mass index = 18.0 to < 35.0 kg/m2.

• Laboratory values must meet acceptable criteria.

• Human Immunodeficiency Virus (HIV-1) infected on antiretroviral therapy (ART) for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.

• CD4 cell count = 450 cells/µL at Screening and during the 12 months prior to Screening.

• Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.

• Participants agreeing to use an effective barrier method of protection (male and/or female condom) during sexual activity from Study Day 1 through last study visit for the purposes of prevention of HIV transmission.

Exclusion Criteria:

• Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.

• Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.

• Participants having history of or active immunodeficiency (other than HIV).

• Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.

• Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4].

• Participants having clinically significant medical disorders that might expose the subjects to undue risk of harm, confound study outcomes, or prevent the subject from completing the study.

• Participants having active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.

• Participants with history of or active tuberculosis (TB) at screening.

• Participants having known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.

• Participants who have received immunomodulatory or immunosuppressive (including IV/orally administered [PO] steroids at any dose, but excluding steroids that are inhaled, topical or via local injection) therapy within 24 weeks prior to the first dose of study drug.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Budigalimab
Subcutaneous (SC)
• Placebo
Subcutaneous (SC)
• Budigalimab
Intravenous (IV)
• Placebo
Intravenous (IV)

Locations

Country	Name	City	State
Puerto Rico	Ponce Medical School Foundation /ID# 224230	Ponce
Puerto Rico	Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936	San Juan
United States	Central Texas Clinical Research /ID# 223937	Austin	Texas
United States	Franco Felizarta, Md /Id# 223931	Bakersfield	California
United States	St. Hope Foundation, Inc. /ID# 224492	Bellaire	Texas
United States	North TX Infectious Diseases /ID# 224494	Dallas	Texas
United States	The Crofoot Research Center, Inc /ID# 224493	Houston	Texas
United States	Ruane Clinical Research Group /ID# 224496	Los Angeles	California
United States	Quest Clinical Research /ID# 223925	San Francisco	California
United States	Peter Shalit, M.D. /ID# 224801	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.	Up to approximately 24 weeks
Primary	Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)	Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines [which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.	Up to approximately 24 weeks
Primary	Maximum Serum Concentration (Cmax)	Maximum Serum Concentration (Cmax) of Budigalimab.	Up to approximately 24 weeks
Primary	Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.	Up to approximately 24 weeks
Primary	Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma	Area Under the Plasma Concentration-time Curve (AUC).	Up to approximately 24 weeks
Primary	Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma	Terminal phase elimination half-life (t1/2)	Up to approximately 24 weeks.