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)

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)

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus (HIV)
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: Budigalimab; Drug: Budigalimab

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico, 00716-0377
    • Ponce Medical School Foundation /ID# 224230
  • San Juan, Puerto Rico, 00935
    • Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
• United States
  • California
    • Bakersfield, California, United States, 93301
      • Franco Felizarta, Md /Id# 223931
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group /ID# 224496
    • San Francisco, California, United States, 94115-3037
      • Quest Clinical Research /ID# 223925
  • Texas
    • Austin, Texas, United States, 78705-3326
      • Central Texas Clinical Research /ID# 223937
    • Bellaire, Texas, United States, 77401-4528
      • St. Hope Foundation, Inc. /ID# 224492
    • Dallas, Texas, United States, 75246
      • North TX Infectious Diseases /ID# 224494
    • Houston, Texas, United States, 77098-3900
      • The Crofoot Research Center, Inc /ID# 224493
  • Washington
    • Seattle, Washington, United States, 98104-3595
      • Peter Shalit, M.D. /ID# 224801

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Placebo SC + Placebo IV; Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo.	Drug: Placebo; Intravenous (IV); Drug: Placebo; Subcutaneous (SC)
Experimental: Group 2: Budigalimab (SC) + Placebo IV; Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.	Drug: Placebo; Intravenous (IV); Drug: Placebo; Subcutaneous (SC); Drug: Budigalimab; Subcutaneous (SC); Other Names: ABBV-181; Drug: Budigalimab; Intravenous (IV); Other Names: ABBV-181
Experimental: Group 3: Budigalimab SC + Placebo IV; Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo.	Drug: Placebo; Intravenous (IV); Drug: Placebo; Subcutaneous (SC); Drug: Budigalimab; Subcutaneous (SC); Other Names: ABBV-181; Drug: Budigalimab; Intravenous (IV); Other Names: ABBV-181
Experimental: Group 4: Placebo SC + Budigalimab IV; Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab.	Drug: Placebo; Intravenous (IV); Drug: Placebo; Subcutaneous (SC); Drug: Budigalimab; Subcutaneous (SC); Other Names: ABBV-181; Drug: Budigalimab; Intravenous (IV); Other Names: ABBV-181

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Maximum Serum Concentration (Cmax)	Maximum Serum Concentration (Cmax) of Budigalimab.	Up to approximately 24 weeks
Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.	Up to approximately 24 weeks
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
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma	Terminal phase elimination half-life (t1/2)	Up to approximately 24 weeks.

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus (HIV); ABBV-181; Budigalimab
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: M19-972

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
• product manufactured in and exported from the U.S.: No