Study Overview

ENERGY is a clinical research study of an investigational medicine to see if it is safe and effective in treating people with warm autoimmune hemolytic anemia (wAIHA). The ENERGY study includes two parts: Double-Blind Period and Open-Label Extension.

The image depicted contains models and is being used for illustrative purposes only.

couple holding hands during walk through field

The image depicted contains models and is being used for illustrative purposes only.

Study Overview

ENERGY is a clinical research study of an investigational medicine to see if it is safe and effective in treating people with warm autoimmune hemolytic anemia (wAIHA). The ENERGY study includes two parts: Double-Blind Period and Open-Label Extension.

Who can enroll in the study?

You may be able to participate if you are:

Age 18 or older

Diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months

Currently receiving treatment for wAIHA or have previously received treatment for wAIHA

Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to being enrolled in
the study. You will visit the study clinic twice for health exams and tests. Not all individuals may qualify for this study.

What can I expect if I join the study?

Double-Blind Period

The first part of the study is the Double-Blind Period, which will include 17 visits over a period of 32 weeks. If you choose to participate you will be randomly assigned to one of three treatment groups.

Group 1 will receive infusions of placebo every two weeks.

study group 1 schedule

Group 2 will receive alternating infusions of the investigational medicine and placebo every two weeks.

study group 2 schedule

Group 3 will receive infusions of the investigational medicine every two weeks.

study group 3 schedule
study group key

You will have a 2 in 3 chance of receiving the investigational medicine and a 1 in 3 chance of receiving only placebo. Neither you nor the study doctor will know the group assignments. No matter which group you are in, you will receive the same level of care.

Open-Label Extension

If you complete the Double-Blind Period, you may have the opportunity to participate in the Open-Label Extension. The Open-Label Extension will include up to 75 visits over the course of 150 weeks. Everyone will receive the investigational medicine in the Open-Label Extension.

Find a Study Site Near You

255 5th Ave.
Nyack, NY 10960
Marion Vonwoudenberg 845-348-8516
Hematology Oncology Associates of Rockland
255 5th Ave.
Nyack, NY 10960
Marion Vonwoudenberg 845-348-8516
3401 Civic Center Blvd
Philadelphia, PA 19104
Michele Lambert, MD 215-590-3437
Children’s Hospital of Philadelphia
3401 Civic Center Blvd
Philadelphia, PA 19104
Michele Lambert, MD 215-590-3437
1430 Tulane Ave, Mail Code 8031
New Orleans, LA 70112
Louisiana Center for Bleeding and Clotting Disorders – Tulane University School of Medicine
1430 Tulane Ave, Mail Code 8031
New Orleans, LA 70112
6740 Antioch Rd
Suite 101
Merriam, KS 66204
Jennifer Ross 913-386-7556
AMR Kansas City Oncology
6740 Antioch Rd
Suite 101
Merriam, KS 66204
Jennifer Ross 913-386-7556
1624 South I Street
Tacoma, WA 98405
Northwest Medical Specialties – Tacoma
1624 South I Street
Tacoma, WA 98405
4500 Brockton Avenue
Suite 107
Riverside, CA 92501
Elsa Honorio 951-276-2760
Compassionate Cancer Care – Riverside
4500 Brockton Avenue
Suite 107
Riverside, CA 92501
Elsa Honorio 951-276-2760

For a complete list of all the site locations, please visit the ENERGY Study page on ClinicalTrials.gov.

FAQ

Each visit will take approximately two hours and may include physical exams, urine tests, blood tests, and/or an EKG.
The IV infusion will take 30 minutes for the first visit and 15 minutes for each visit thereafter.

What is a clinical trial?

A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation conducted by doctors and researchers to determine if an investigational medicine, device, or procedure is safe or effective.

Trials are conducted in four phases:

phase 1

Phase I trials examine the safety of an investigational medicine in healthy people

phase 2

Phase 2 trials involve assessment of safety and additional efficacy and establishing the best dosing regimen while testing safety in patients.

phase 3

Phase 3 trials confirm the efficacy and safety of an investigational medicine in patients.

phase 4

Phase 4 trials are conducted after an investigational medicine has been approved to gather additional efficacy and safety information.