Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis

An Open-label, Single-arm, Multi-center Study to Evaluate the Long-term Safety and Efficacy of AK101 Injection in Subjects With Moderate-to-severe Plaque Psoriasis

This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.

Study Overview

• Status: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Biological: AK101 injection SC

Detailed Description

This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.

• Study Type: Interventional
• Enrollment (Anticipated): 950
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guoqin Wang, Doctor; Phone Number: +86 (0760) 8987 3998; Email: global.trials@akesobio.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:

  1. Subjects can continue to participate in this study based on assessment of investigator.
  2. Subjects voluntarily participate in this study.
  3. Subjects who are women of childbearing potential must be practicing an adequate, medically acceptable method of birth control during the treatment period and for at least 6 months after the last study drug administration.

• Applicable for subjects newly enrolled:

  1. Male or female subjects aged ≥ 18 years old.
  2. Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment.
  3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
  4. Subjects who are applicable for biological agents, based on the assessment of investigator.
  5. Subjects who are women of childbearing potential must have a negative pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 6 months after the last study drug administration.

Key Exclusion Criteria:

• Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:

  1. Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection.
  2. Subjects who used prohibited drugs in an Akeso trial with AK101 injection.
  3. Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator.
  4. Subjects with any other disease, abnormal physical examination or abnormal laboratory examination leading to inapplicable for participating this study, based on the assessment of investigator.

• Applicable for subjects newly enrolled:

  1. Forms of psoriasis other than chronic plaque-type psoriasis.
  2. History or evidence of active TB. Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment had initiated and maintained according to protocol.
  3. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis.
  4. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening.
  5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.
  6. History of IL-12/23 or IL-23 inhibitors therapy.
  7. Inadequate washout period of prior biological therapy.
  8. History of malignant tumour within 5 years before screening.
  9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator would place the subject at risk, interfere with participation or interpretation of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AK101 135mg; Subjects who have completed AK101-302 receive AK101 135mg injection subcutaneously every 12 weeks. Subjects newly enrolled receive AK101 135mg injection subcutaneously at Week 0, 4 and then every 12 weeks.	Biological: AK101 injection SC; AK101 is supplied as 135 mg doses, provided in 1 mL prefilled syringes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Treatment-Emergent Adverse Event	To evaluate long-term safety as assessed by occurrence of TEAE.	up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Serious Adverse Event and Adverse Events of Special Interest	To evaluate long-term safety as assessed by occurrence of SAE and AESI.	up to 52 weeks
Percentage of Subjects Who Achieved at least 50% (PASI 50), 75% (PASI 75) and 90% (PASI 90) Reduction in Psoriasis Area and Severity Index (PASI) Score	PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50, PASI75 and PASI 90 were defined as participants achieving >= 50%, >= 75% or >= 90% improvement from baseline, respectively.	up to 52 weeks
Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)	The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe.	up to 52 weeks
Pharmacokinetics Assessment of AK101 Serum Concentration		up to 52 weeks
Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)		up to 52 weeks

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2022
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (ACTUAL): August 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: AK101-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No