Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (PAD PoC)

Novartis

Status and phase: Completed; Phase 2

Conditions: Peripheral Artery Disease (PAD); Intermittent Claudication

Treatments: Drug: LLG783; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03194776

CLLG783X2201

2017-000706-37 (EudraCT Number)

Details and patient eligibility

About

This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.

Enrollment: 46 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• claudication, as defined by pain with exertion in either leg;

• On stable medical therapy, including statins, aspirin, and antihypertensive medications (as medically indicated) unless individually contraindicated, for at least 4 weeks prior to the screening visit;

• Vital signs must be within the following ranges:

  • body temperature between 35.0-37.5°C
  • systolic blood pressure, 90-159 mm Hg
  • diastolic blood pressure, 50-99 mm Hg
  • pulse rate, 50 - 90 bpm

• Moderately impaired ambulatory function judged by the investigator to be due primarily to PAD and assessed by a maximum walk distance between 50 and 400 meters (inclusive of these values) at the screening 6-minute walk test (6MWT).

Exclusion criteria

• Pregnant or nursing (lactating) women;

• Patients who meet any of the following PAD related criteria:

  • Patients actively attending and participating in a supervised exercise rehabilitation program (patients who have already completed such a program and remain symptomatic may be included).
  • Patients with any condition other than PAD that limits walking ability.
  • Known inflammatory disease of the arteries (other than atherosclerosis; e.g. Thromboangiitis obliterans).
  • Clinical evidence of critical limb ischemia including new or non-healing ulcers (felt secondary to critical limb ischemia), new or recent onset of resting pain in the lower extremities particularly at night (felt secondary to critical limb ischemia) and/or gangrene of the lower extremities (Fontaine stage III-IV) .

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 150 days after stopping of investigational drug.

• Any of the following concomitant cardiovascular or metabolic conditions or diseases:

  • Myocardial infarction within 6 months of screening.
  • Stroke within 6 months of screening.
  • History of clinically significant ventricular arrhythmias, according to the discretion of the investigator, within 6 months of screening.
  • Significant ECG abnormalities, according to the discretion of the investigator, at screening.
  • History of sustained and clinically significant supraventricular arrhythmias (e. g. associated with hemodynamic compromise) within 6 months of screening.
  • Chronic heart failure New York Heart Association Class III or IV.
  • Known presence of aortic aneurysm > 5 cm.
  • Uncontrolled diabetes as defined by a random fasting glucose level of 13 mmol/L or 240 mg/dL or a HbA1c greater than 9% as measured at screening. Diabetes should be treated as appropriate during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups, including a placebo group

LLG783

Experimental group

Description:

Patients will receive LLG783 i.v. infusion every 4 weeks for 12 weeks.

Treatment:

Drug: LLG783

Placebo

Placebo Comparator group

Description:

Patients will receive placebo to LLG783 i.v. infusion every 4 weeks for 12 weeks.

Treatment:

Drug: Placebo