Psoriasis VulgarisPhase 3NCT05120297

A Phase 3 Study of Efficacy and Safety of AK101 in Subjects With Psoriasis

A Phase 3 study testing AK101 in people with Psoriasis Vulgaris, run by Akeso at 52 sites in China.

Completed

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

Trial summary

This is a randomized, double-blind, placebo-controlled, multicentered phase III clinical study to evaluate the efficacy and safety of AK101 in the treatment of 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: Psoriasis Vulgaris
What is being tested?: AK101
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 452 participants
Where: 52 sitesChina
Study dates: 29 Nov 2021to 29 Sep 2022
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

Male or female subjects aged ≥ 18 years.
Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
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

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 IL12/23 or IL-23 inhibitors therapy.

Show all 9Show fewer

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

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

China52 sites

AkesoBio Investigative Site 1001
Beijing, Beijing Municipality
AkesoBio Investigative Site 1027
Beijing, Beijing Municipality
AkesoBio Investigative Site 1034
Beijing, Beijing Municipality
AkesoBio Investigative Site 1035
Beijing, Beijing Municipality
AkesoBio Investigative Site 1036
Beijing, Beijing Municipality
AkesoBio Investigative Site 1049
Beijing, Beijing Municipality
AkesoBio Investigative Site 1051
Beijing, Beijing Municipality
AkesoBio Investigative Site 1010
Bengbu, Anhui
AkesoBio Investigative Site 1032
Changchun, Jilin
AkesoBio Investigative Site 1047
Changchun, Jilin
AkesoBio Investigative Site 1006
Changsha, Hunan
AkesoBio Investigative Site 1026
Changsha, Hunan
AkesoBio Investigative Site 1025
Chengde, Hebei
AkesoBio Investigative Site 1011
Chengdu, Sichuan
AkesoBio Investigative Site 1041
Chongqing, Chongqing Municipality
AkesoBio Investigative Site 1008
Dalian, Liaoning
AkesoBio Investigative Site 1007
Guangzhou, Guangdong
AkesoBio Investigative Site 1021
Guangzhou, Guangdong
AkesoBio Investigative Site 1024
Guangzhou, Guangdong
AkesoBio Investigative Site 1039
Guiyang, Guizhou
AkesoBio Investigative Site 1002
Hangzhou, Zhejiang
AkesoBio Investigative Site 1003
Hangzhou, Zhejiang
AkesoBio Investigative Site 1022
Hangzhou, Zhejiang
AkesoBio Investigative Site 1014
Harbin, Heilongjiang
AkesoBio Investigative Site 1028
Hefei, Anhui
AkesoBio Investigative Site 1050
Hohhot, Neimenggu
AkesoBio Investigative Site 1038
Jinan, Shandong
AkesoBio Investigative Site 1042
Jinan, Shandong
AkesoBio Investigative Site 1037
Kunming, Yunnan
AkesoBio Investigative Site 1052
Lianyungang, Jiangsu
AkesoBio Investigative Site 1019
Nanchang, Jiangxi
AkesoBio Investigative Site 1020
Nanchang, Jiangxi
AkesoBio Investigative Site 1029
Nanjing, Jiangsu
AkesoBio Investigative Site 1012
Nanning, Guangxi
AkesoBio Investigative Site 1033
Nanyang, Henan
AkesoBio Investigative Site 1043
Qingdao, Shandong
AkesoBio Investigative Site 1005
Shanghai, Shanghai Municipality
AkesoBio Investigative Site 1048
Shenyang, Liaoning
AkesoBio Investigative Site 1018
Shenzhen, Guangdong
AkesoBio Investigative Site 1023
Shenzhen, Guangdong
AkesoBio Investigative Site 1030
Shenzhen, Guangdong
AkesoBio Investigative Site 1017
Shijiazhuang, Hebei
AkesoBio Investigative Site 1031
Shijiazhuang, Hebei
AkesoBio Investigative Site 1016
Suining, Sichuan
AkesoBio Investigative Site 1046
Taiyuan, Shanxi
AkesoBio Investigative Site 1040
Tianjin, Tianjin Municipality
AkesoBio Investigative Site 1004
Wuhan, Hubei
AkesoBio Investigative Site 1013
Wuhu, Anhui
AkesoBio Investigative Site 1009
Xuzhou, Jiangsu
AkesoBio Investigative Site 1015
Yancheng, Jiangsu
AkesoBio Investigative Site 1044
Yinchuan, Ningxia
AkesoBio Investigative Site 1045
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study. The purpose of this study is to evaluate the efficacy and safety of AK101 in the treatment of subjects with moderate-to- severe plaque psoriasis. Subjects will be randomized to receive AK101 or placebo injection subcutaneously, and follow up to week 16.

Conditions: Psoriasis Vulgaris
Being tested: AK101, Placebo

What participants receive

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

AK101Drug
Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.
PlaceboDrug
Subjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.

Study groups in NCT05120297
Study group	Role	What they receive
AK101	Experimental	Not described Receives: Drug: AK101
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
Measured: At week 16
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
Measured: At week 16

Secondary outcomes (6)

Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit.
Measured: Baseline to week 16
Percentage of subjects who achieved sPGA 0/1 at each visit.
Measured: Baseline to week 16
Percentage change of PASI from baseline.
Measured: Baseline to week 16
PK: AK101 serum concentration at different time points after administration.
Measured: Baseline to week 16
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Measured: Baseline to week 16
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).
Measured: Baseline to week 16

Timeline

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

29 Nov 202129 Sep 2022

First posted15 Nov 2021
Study start29 Nov 2021
Primary completion29 Sep 2022
Study completion29 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
More trials run by AkesoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05120297
Sponsor's protocol ID: AK101-302
Status last verified: Mar 2023
First submitted: 3 Nov 2021
Last updated: 2 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris

All Psoriasis Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Efficacy and Safety of AK101 in Subjects With Moderate-to-severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT05120297
Acronym / sponsor ID: AK101-302
Conditions: Psoriasis Vulgaris
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 452 participants (actual)
Lead sponsor: AkesoIndustry (pharma, biotech, devices)
Study start: 29 Nov 2021 (actual)
Primary completion: 29 Sep 2022 (actual)
Study completion: 29 Sep 2022 (actual)
First posted: 15 Nov 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
AK101	Experimental	Drug: AK101
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female subjects aged ≥ 18 years.
Subjects diagnosed with moderate-to-severe plaque psoriasis for at least 6 months before screening.
At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%, sPGA ≥ 3.
Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
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 (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AK101Subjects will receive AK101 subcutaneous injection at week 0 and week 4, and will follow up to week 16.	Drug	AK101
PlaceboSubjects will receive placebo subcutaneous injection at week 0 and week 4, and will follow up to week 16.	Drug	Placebo

Primary outcome

Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline.
Time frame: At week 16
Percentage of subjects who achieved static physician global assessment (sPGA) clearance or very slight (0/1).
Time frame: At week 16

6 secondary outcomes

Percentage of subjects who achieved at least 50% (PASI 50), 75% (PASI75, except week 16) and 90% (PASI 90) reduction in PASI score at each visit.
Time frame: Baseline to week 16
Percentage of subjects who achieved sPGA 0/1 at each visit.
Time frame: Baseline to week 16
Percentage change of PASI from baseline.
Time frame: Baseline to week 16
PK: AK101 serum concentration at different time points after administration.
Time frame: Baseline to week 16
Immunogenicity assessment: number and percentage of subjects with detectable anti-AK101 antibody (ADA).
Time frame: Baseline to week 16
Safety: Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE).
Time frame: Baseline to week 16

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
Individual participant dataSharing planned: No

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
Psoriasis, Psoriasis; Plaque
RecruitingPhase 1
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
Psoriasis Vulgaris

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK101 in people with Psoriasis Vulgaris, run by Akeso at 52 sites 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 5 inclusion and 9 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites 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. Some participants in this study may receive a placebo. 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?

Percentage of subjects who achieved at least 75% (PASI 75) reduction in psoriasis area and severity index (PASI) score from baseline. (time frame: At week 16). The study lists 2 primary outcomes in all. 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 NCT05120297.

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 2 Mar 2023.