A Phase II Trial of Safety, Tolerability and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.
A Phase II, Randomized, Placebo-Controlled, Double Blind, Trial of Safety, Tolerability and Efficacy Study of Topical AKP-11 Administration to Participants with Arthritis.
Akaal Pharma PTY LTD
100 participants
May 2, 2018
Interventional
Conditions
Summary
A primary purpose of this study is to evaluate Safety, Tolerability and Efficacy of Topical AKP-11 Administration to Participants with Arthritis. AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist developed to treat multiple pathological events common in arthritis. The study consists of 2 parts: PART A investigates two doses of AKP-11 over 7 days in 20 participants (2 cohorts of 10 participants each) with arthritis. Each cohort will have 8 participants on AKP-11 and 2 participants on placebo. PART B will select the dose identified in PART A and will be conducted with treatment over 21 days in 80 participants with arthritis, The dose of AKP-11 will be selected after the safety profile and efficacy of AKP-11 has been determined. The participants will be randomized to receive AKP-11 or Placebo in a ratio of 1:1.
Eligibility
Plain Language Summary
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Interventions
AKP-11 is a Sphingosine-1-phosphate receptor 1 (S1P1) agonist and 0.5 g of study gel will be topically applied 4 times a day (total daily application of 2 g).The study consists of 2 parts: PART A investigates two doses of AKP-11 (daily dose 3% (60 mg) and 6% (120 mg) over 7 days in 20 participants (2 cohorts of 10 participants each) with osteoarthritis. Each cohort will have 8 participants on AKP-11 and 2 participants on placebo. PART B will select the dose identified in PART A and will be conducted with treatment over 21 days in 80 participants with osteoarthritis, rheumatoid arthritis or gout. The dose of AKP-11 will be selected after the safety profile and efficacy of AKP-11 has been determined (dose selected will be in the range of 3 to 6%). The participants will be randomized to receive AKP-11 or Placebo in a ratio of 1:1. PART A: 20 osteoarthritis participants PART B: 80 arthritis participants The participants will return all used and unused sachets to the study staff for accountability purposes.
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ACTRN12617001223325