A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants

NCT ID: NCT02093923

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-14
• Study Completion Date: 2015-05-18

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.

Conditions

Hereditary Angioedema (HAE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DX-2930, Cohort 1

Participants will receive 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.

Group Type: EXPERIMENTAL

DX-2930

Intervention Type: DRUG

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

DX-2930, Cohort 2

Participants will receive 100 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm.

Group Type: EXPERIMENTAL

DX-2930

Intervention Type: DRUG

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

DX-2930, Cohort 3

Participants will receive 300 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm.

Group Type: EXPERIMENTAL

DX-2930

Intervention Type: DRUG

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

DX-2930, Cohort 4

Participants will receive 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm.

Group Type: EXPERIMENTAL

DX-2930

Intervention Type: DRUG

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

Placebo

Participants will receive placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive matching placebo subcutaneously.

Interventions

DX-2930

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo subcutaneously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age at the time of screening
• Documented diagnosis of HAE (Type I or II)
• Experiencing ≥2 HAE attacks per year, with at least 1 attack in the past 6 months reported by the participant
• Willing and able to read, understand, and sign an informed consent form
• Females of childbearing potential must agree to be abstinent or else use acceptable forms of contraception throughout study
• Males with female partners of childbearing potential must agree to be abstinent or use a medically acceptable form of contraception throughout study

Exclusion Criteria

• Exposure to an investigational drug or device within 90 days prior to study
• History of exposure within the past 5 years to a monoclonal antibody or recombinant protein bearing an Fc domain
• Concomitant diagnosis of another form of chronic angioedema
• Use of long-term prophylaxis for HAE within 90 days prior to study
• Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study; any use of C1-INH within 7 days prior to study
• Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption within 90 days prior to study
• Exposure to androgens within 90 days prior to study
• Presence of an indwelling catheter
• Diagnosis of HIV
• Active liver disease or liver function test abnormalities
• History of substance abuse or dependence
• Pregnancy or breastfeeding
• Any condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

UC San Diego Health System - La Jolla

San Diego, California, United States

Allergy & Asthma Clinical Research

Walnut Creek, California, United States

University of South Florida Asthma, Allergy or Immunology Clinical Research Unit

Tampa, Florida, United States

Institute for Asthma & Allergy, PC

Chevy Chase, Maryland, United States

Massachusetts General Hospital Allergy Associates

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Winthrop-University Hospital, Clinical Trials Center

Mineola, New York, United States

Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center

New York, New York, United States

UC Physicians Company

Cincinnati, Ohio, United States

Baker Allergy, Asthma and Dermatology Research Center

Lake Oswego, Oregon, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

AARA Research Center

Dallas, Texas, United States

Ospedale L. Sacco

Milan, MI, Italy

Jordan University Hospital

Amman, , Jordan

Countries

United States; Italy; Jordan

References

Banerji A, Busse P, Shennak M, Lumry W, Davis-Lorton M, Wedner HJ, Jacobs J, Baker J, Bernstein JA, Lockey R, Li HH, Craig T, Cicardi M, Riedl M, Al-Ghazawi A, Soo C, Iarrobino R, Sexton DJ, TenHoor C, Kenniston JA, Faucette R, Still JG, Kushner H, Mensah R, Stevens C, Biedenkapp JC, Chyung Y, Adelman B. Inhibiting Plasma Kallikrein for Hereditary Angioedema Prophylaxis. N Engl J Med. 2017 Feb 23;376(8):717-728. doi: 10.1056/NEJMoa1605767.

Reference Type: DERIVED

PMID: 28225674 (View on PubMed)

Other Identifiers

DX-2930-02

Identifier Type: -

Identifier Source: org_study_id