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Plaque PsoriasisPhase 3NCT05509361

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

A Phase 3 study testing AK101 injection SC in people with Plaque Psoriasis, run by Akeso at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plaque Psoriasis
What is being tested?
AK101 injection SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
950 participants
Where
1 siteChina
Study dates
8 Apr 2022to 24 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking university people's hospital

    Beijing

Other trials in China

About this study

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

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.

Read the 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.

Being tested
AK101 injection SC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK101 injection SCBiological

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

Study groups in NCT05509361
Study groupRoleWhat they receive
AK101 135mgExperimentalSubjects 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.
Receives: Biological: AK101 injection SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment-Emergent Adverse Event

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

    Measured: up to 52 weeks

Secondary outcomes (5)

  1. Occurrence of Serious Adverse Event and Adverse Events of Special Interest

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

    Measured: up to 52 weeks

  2. 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.

    Measured: up to 52 weeks

  3. 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.

    Measured: up to 52 weeks

  4. Pharmacokinetics Assessment of AK101 Serum Concentration

    Measured: up to 52 weeks

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

    Measured: up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start8 Apr 2022
  3. Primary completion24 Nov 2023
  4. Study completion24 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
950 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509361
Sponsor's protocol ID
AK101-303
Status last verified
Jun 2024
First submitted
18 Aug 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK101 injection SC in people with Plaque Psoriasis, run by Akeso at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Treatment-Emergent Adverse Event (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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