Systemic SclerosisPhase 1NCT04368403

A Study of KHK4827 in Patients With Systemic Sclerosis

A Phase 1 study testing KHK4827 in people with Systemic Sclerosis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

Completed

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

Trial summary

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Systemic Sclerosis
What is being tested?: KHK4827
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteJapan
Study dates: 6 Oct 2017to 31 Mar 2025
Phase: Phase 1
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to <30 at the pre-examination and who has progressing skin thickening

Who cannot join

Any of the following significant concomitant diseases:
Type 1 diabetes
Poorly controlled type 2 diabetes (HbA1c > 8.5%)
Congestive heart failure (Class II to IV of the New York Heart Association Functional Classification)
Myocardial infarction, unstable angina, or stroke occurring within 12 months before the first dose of investigational product
Poorly controlled hypertension (systolic pressure > 150 mm Hg or diastolic pressure > 90 mg Hg at screening)

Show all 11Show fewer

Severe chronic lung disease (%Forced Vital Capacity (FVC) < 60% and %Diffusing capacity of lung for carbon monoxide (DLco) < 40%, calculated according to the Reference Values for Spirometry, Including Viral Capacity, in Japanese Adults Calculated with the LMS Method and Compared with Previous Values [Japanese Respiratory Society])
Major chronic inflammatory diseases or connective tissue diseases other than scleroderma
Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment

Trial locations and contacts

1 site in 1 country.

Japan1 site

The University of Tokyo Hospital
Bunkyo-ku, Tokyo, 113-8655

Other trials in Japan

About this study

Official title: A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis

Conditions: Systemic Sclerosis
Being tested: KHK4827
Keywords: systemic sclerosis, brodalumab, KHK4827
Medical subject headings: Scleroderma, Systemic

What participants receive

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

KHK4827Drug
210 mg every 2 weeks (Q2W), subcutaneous (SC) injection

Study groups in NCT04368403
Study group	Role	What they receive
KHK4827	Experimental	Not described Receives: Drug: KHK4827

What is being measured

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

serum KHK4827 concentration
Measured: Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.

Secondary outcomes (1)

Change in modified Rodnan skin score (mRSS) from baseline
mRSS: scored 0(normal), 1(mild), 2(moderate), or 3(severe) per each site, assessed in 17 different body sites, total score=51
Measured: Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.

Timeline

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

6 Oct 201731 Mar 2025

First posted29 Apr 2020
Study start6 Oct 2017
Primary completion31 Jan 2019
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Systemic SclerosisStudies of the same condition, open and under way.
More trials run by Kyowa Kirin Co., Ltd.The 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04368403
Sponsor's protocol ID: 4827-007
Status last verified: Jul 2025
First submitted: 13 Apr 2020
Last updated: 11 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Publications

Fukasawa T, Yoshizaki A, Ebata S, Fukayama M, Kuzumi A, Norimatsu Y, Matsuda KM, Kotani H, Sumida H, Yoshizaki-Ogawa A, Kagebayashi H, Sato S. Interleukin-17 pathway inhibition with brodalumab in early systemic sclerosis: Analysis of a single-arm, open-label, phase 1 trial. J Am Acad Dermatol. 2023 Aug;89(2):366-369. doi: 10.1016/j.jaad.2023.02.061. Epub 2023 Mar 29. No abstract available.
PubMed 36997069

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

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A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
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Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
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All Systemic Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Multiple-dose Study of KHK4827 in Subjects With Systemic Sclerosis
ClinicalTrials.gov ID: NCT04368403
Acronym / sponsor ID: 4827-007
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis, brodalumab, KHK4827
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Study start: 6 Oct 2017 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 29 Apr 2020 (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.

Exploratory evaluation of pharmacokinetics and safety of KHK4827 in subjects with systemic sclerosis

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
KHK4827	Experimental	Drug: KHK4827

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject meets the criteria for diagnosis of the Diagnostic Criteria, Severity Classification, and Clinical Practice Guidelines for Systemic Sclerosis （Japanese Dermatological Association 2016） at the pre-examination
Subject presented the first symptoms of sclerosis other than Raynaud's phenomenon within 60 months before enrollment
Subject who has systemic sclerosis accompanied by moderate to severe skin thickening with an mRSS of 10 to <30 at the pre-examination and who has progressing skin thickening

Key exclusion criteria (11 listed)

Any of the following significant concomitant diseases:
Patient has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse, or any other mental health disorder that, in the opinion of the investigators, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Patient has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
Patient has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment

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
KHK4827210 mg every 2 weeks (Q2W), subcutaneous (SC) injection	Drug	KHK4827

Primary outcome

serum KHK4827 concentration
Time frame: Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.

1 secondary outcome

Change in modified Rodnan skin score (mRSS) from baseline
Time frame: Pre-dose, Week 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and every 8 weeks through study completion until 2025.

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 11 Jul 2025.
Derived from this study: PubMed 36997069Fukasawa T, Yoshizaki A, Ebata S, Fukayama M, Kuzumi A, Norimatsu Y, Matsuda KM, Kotani H, Sumida H, Yoshizaki-Ogawa A, Kagebayashi H, Sato S. Interleukin-17 pathway inhibition with brodalumab in early systemic sclerosis: Analysis of a single-arm, open-label, phase 1 trial. J Am Acad Dermatol. 2023 Aug;89(2):366-369. doi: 10.1016/j.jaad.2023.02.061. Epub 2023 Mar 29. No abstract available.
Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.

Related trials for Systemic Sclerosis

Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KHK4827 in people with Systemic Sclerosis, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

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 3 inclusion and 11 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 11 Jul 2025. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

serum KHK4827 concentration (time frame: Pre-dose, Week 1, 2, 4, 8, 12, 16, 22, 24, 36, 48, 52 and every 24 weeks through study completion until 2025.). 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 NCT04368403, which also lists 1 linked publication.

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 11 Jul 2025.