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)

• ClinicalTrials.gov Identifier: NCT04799353
• Recruitment Status: Recruiting
• First Posted: March 16, 2021
• Last Update Posted: December 15, 2021
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus (HIV)	Drug: Budigalimab; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: March 15, 2021
• Estimated Primary Completion Date: October 2, 2022
• Estimated Study Completion Date: October 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs) [ Time Frame: Up to approximately 24 weeks ]
   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.
2. Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE) [ Time Frame: Up to approximately 24 weeks ]
   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.
3. Maximum Serum Concentration (Cmax) [ Time Frame: Up to approximately 24 weeks ]
   Maximum Serum Concentration (Cmax) of Budigalimab.
4. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to approximately 24 weeks ]
   Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
5. Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma [ Time Frame: Up to approximately 24 weeks ]
   Area Under the Plasma Concentration-time Curve (AUC).
6. Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma [ Time Frame: Up to approximately 24 weeks. ]
   Terminal phase elimination half-life (t1/2)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

Locations

United States, California

Franco Felizarta, Md /Id# 223931; Recruiting

Bakersfield, California, United States, 93301

Ruane Clinical Research Group /ID# 224496; Recruiting

Los Angeles, California, United States, 90036

Quest Clinical Research /ID# 223925; Recruiting

San Francisco, California, United States, 94115-3037

United States, Texas

Central Texas Clinical Research /ID# 223937; Recruiting

Austin, Texas, United States, 78705-3326

St. Hope Foundation, Inc. /ID# 224492; Recruiting

Bellaire, Texas, United States, 77401-4528

North TX Infectious Diseases /ID# 224494; Recruiting

Dallas, Texas, United States, 75246

The Crofoot Research Center, Inc /ID# 224493; Recruiting

Houston, Texas, United States, 77098-3900

United States, Washington

Peter Shalit, M.D. /ID# 224801; Recruiting

Seattle, Washington, United States, 98104-3595

Puerto Rico

Ponce Medical School Foundation /ID# 224230; Recruiting

Ponce, Puerto Rico, 00716-0377

Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936; Recruiting

San Juan, Puerto Rico, 00935

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

More Information

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04799353
• Other Study ID Numbers: M19-972
• First Posted: March 16, 2021
• Last Update Posted: December 15, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by AbbVie:

Human Immunodeficiency Virus (HIV); Budigalimab; ABBV-181

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases