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Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT04173637
Recruitment Status : Not yet recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Akeso Tiancheng, Inc
Information provided by (Responsible Party):
Akeso

Brief Summary:
This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Biological: AK101 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Placebo-controlled, Phase IIb Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AK101 45mg every 8 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Experimental: AK101 45mg - every 12 weeks
AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Experimental: AK101 90mg - every 8 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Experimental: AK101 90mg -every 12 weeks
AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Experimental: AK101 135mg -every 8 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Experimental: AK101 135mg -every 12 weeks
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Placebo Comparator: Placebo to AK101
Placebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks
Biological: AK101
an anti-IL-12/23p40 monoclonal antibody

Biological: Placebo
matching placebo




Primary Outcome Measures :
  1. Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12 [ Time Frame: Week 12 ]
  2. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: From the time of signing the informed consent form till last follow-up visit (Up to Week 52) ]

Secondary Outcome Measures :
  1. Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12 [ Time Frame: At baseline and Week 12 ]
  2. Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) [ Time Frame: Up to Week 52 (except for Week 12) ]
  3. Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) [ Time Frame: Up to Week 52( except for Week 12) ]
  4. Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12 [ Time Frame: Up to Week 52 ]
  5. Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline [ Time Frame: Up to Week 52 ]
    The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall Qol, can be used to assess six different aspects that mey affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment.

  6. Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment [ Time Frame: Up to Week 52 ]
  7. Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: Up to Week 52 ]
    The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs)

  8. Minimum observed concentration (Cmin) of AK101 at steady state [ Time Frame: Up to Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have had Plaque Psoriasis diagnosed at least 6 months prior to screening.
  2. Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area. Psoriasis area and severity index(PASI) ≥12. Physicians Global Assessment score ≥3.
  3. Candidate for systemic therapy, defined as having psoriasis inadequately controlled by topical treatment (including topical corticosteroids) and/or phototherapy and/or previous systemic therapy.
  4. Women of childbearing potential should not be in pregnancy or lactation, men and women of childbearing potential must agree to use adequate birth control measures during study participation and for 6 months after the last doses of study treatment.
  5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.
  6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.

Exclusion Criteria:

  1. Had nonplaque forms of psoriasis (e.g., Guttate, erythrodermic, or pustular).
  2. Had other active skin diseases or skin infections (e.g., Bacterial, fungal or viral infection) that could affect psoriasis evaluation.
  3. Had imaging diagnosis of pulmonary infection or fibrosis during the 3 months prior to screening.
  4. History or evidence of active or latent tuberculosis at screening.
  5. Serious systemic infections or local infections during the 2 months prior to screening.
  6. History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
  7. Known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
  8. Known history of alcohol or drug abuse.
  9. History or known presence of recurrent or chronic infection (e.g., hepatitis or C, human immunodeficiency virus [HIV], syphilis, TB).
  10. Had received any DMARDs (e.g., Anti-malaria drug, retinoids, interferon, lithium) during 2 weeks prior to screening.
  11. Had received any physical therapy (e.g., PUVA, ultra-violet therapy, tanning beds) during 2 weeks prior to screening.
  12. Had received any systemic psoriasis therapy (e.g., Glucocorticoid, retinoids, ciclosporin, methotrexate, or tripterygium) during 4 weeks prior to screening.
  13. Had enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
  14. Had received previous treatment with any anti-IL-12/IL-23, IL-12, IL-23, IL-17 therapy for the treatment of psoriasis or psoriatic arthritis.
  15. Had received natalizumab or any other drugs that regulate B cells or T cells (rituximab, abatacept, alemtuzumab) during 12 months prior to screening.
  16. Had received other biologic therapy (e.g., TNF inhibitor) during 6 months prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173637


Contacts
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Contact: Miao Wang, PhD +86-0760-89873999 clinicaltrials@akesobio.com

Locations
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China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Principal Investigator: Hongzhong Jin, MD         
Peking University People's Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Principal Investigator: Jianzhong Zhang, MD         
Sponsors and Collaborators
Akeso
Akeso Tiancheng, Inc
Investigators
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Principal Investigator: Jianzhong Zhang, MD Peking University People's Hospital
Principal Investigator: Hongzhong Jin, MD Peking Union Medical College Hospital

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Responsible Party: Akeso
ClinicalTrials.gov Identifier: NCT04173637     History of Changes
Other Study ID Numbers: AK101-301
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akeso:
IL12/23
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases