Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication
Condition: Peripheral Artery Disease (PAD); Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Intervention: LLG783; Placebo
Intervention description: LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.; Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, patient and investigator-blinded, placebo controlled, parallel group study
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: PAD; peripheral artery/arterial disease; peripheral vascular disease; leg pain; claudication; leg pain with exercise; exercise test; walk test

Summary:

      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.
    

Eligibility criteria:

        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.