RecruitingPhase 2ACTRN12617001223325

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.


Sponsor

Akaal Pharma PTY LTD

Enrollment

100 participants

Start Date

May 2, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a new topical (applied to the skin) medication called AKP-11 for people with arthritis — including osteoarthritis, gout, and rheumatoid arthritis. AKP-11 works differently from standard anti-inflammatory creams; it targets a pathway in the immune system called S1P1. Part A of the study tests two doses over 7 days in people with osteoarthritis. Part B tests the selected dose over 21 days in people with any form of inflammatory arthritis. The aim is to see whether AKP-11 is safe, tolerable, and able to reduce pain and swelling. You may be eligible if: - You are between 18 and 75 years old - You have arthritis (osteoarthritis in Part A; or gout, osteoarthritis, or rheumatoid arthritis in Part B) - Your pain level is at least 4 out of 10 - Your condition has been stable for at least 2 weeks - You are willing to use contraception during the study if you are of childbearing potential You may NOT be eligible if: - You are allergic to any ingredient in the study cream - You are currently taking immunosuppressant drugs or systemic steroids - You have an active cancer or a major immune disease (other than rheumatoid arthritis) - You have recently had joint surgery - You are pregnant or planning to become pregnant Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 inv

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.


Locations(1)

SA, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12617001223325