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

Primary Purpose

Plaque Psoriasis

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

AK101 injection SC

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking university people's hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AK101 135mg

Arm Description

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.

Outcomes

Primary Outcome Measures

Occurrence of Treatment-Emergent Adverse Event

To evaluate long-term safety as assessed by occurrence of TEAE.

Secondary Outcome Measures

Occurrence of Serious Adverse Event and Adverse Events of Special Interest

To evaluate long-term safety as assessed by occurrence of SAE and AESI.

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.

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.

Pharmacokinetics Assessment of AK101 Serum Concentration

Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)

Full Information

NCT ID

NCT05509361

First Posted

August 18, 2022

Last Updated

August 23, 2022

Sponsor

Akeso

1. Study Identification

Unique Protocol Identification Number

NCT05509361

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 8, 2022 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plaque Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AK101 135mg

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

AK101 injection SC

Intervention Description

AK101 is supplied as 135 mg doses, provided in 1 mL prefilled syringes.

Primary Outcome Measure Information:

Title

Occurrence of Treatment-Emergent Adverse Event

Description

To evaluate long-term safety as assessed by occurrence of TEAE.

Time Frame

up to 52 weeks

Secondary Outcome Measure Information:

Title

Occurrence of Serious Adverse Event and Adverse Events of Special Interest

Description

To evaluate long-term safety as assessed by occurrence of SAE and AESI.

Time Frame

up to 52 weeks

Title

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

Description

Time Frame

up to 52 weeks

Title

Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)

Description

Time Frame

up to 52 weeks

Title

Pharmacokinetics Assessment of AK101 Serum Concentration

Time Frame

up to 52 weeks

Title

Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)

Time Frame

up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection: Subjects can continue to participate in this study based on assessment of investigator. Subjects voluntarily participate in this study. 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: Male or female subjects aged ≥ 18 years old. Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to systematic treatment. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3. Subjects who are applicable for biological agents, based on the assessment of investigator. 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: Subjects who have severe AE or SAE occurred in an Akeso trial with AK101 injection. Subjects who used prohibited drugs in an Akeso trial with AK101 injection. Subjects performed poor compliance in an Akeso trial with AK101 injection, based on the assessment of investigator. 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: Forms of psoriasis other than chronic plaque-type psoriasis. 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. Positive results of confirmatory test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis. History of repeated chronic infection, had any serious infection or systemic infection within 2 months before screening. History of prohibited psoriasis treatments within 2/4 weeks before randomization. History of IL-12/23 or IL-23 inhibitors therapy. Inadequate washout period of prior biological therapy. History of malignant tumour within 5 years before screening. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guoqin Wang, Doctor

Phone

+86 (0760) 8987 3998

global.trials@akesobio.com

Facility Information:

Facility Name

Peking university people's hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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