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Arthritis, RheumatoidPhase 1NCT05304130

A Study in Healthy Japanese Participants to Evaluate the Safety and Pharmacokinetics of Otilimab

A Phase 1 study testing Otilimab in people with Arthritis, Rheumatoid, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Otilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
8 Feb 2023to 4 May 2023
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 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant must be 20 to 50 years of age inclusive, at the time of signing the informed consent.
  • Japanese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • A Coronavirus Disease-2019 (COVID-19) screening with negative test: Two consecutive approved molecular tests (Polymerase chain reaction [PCR] or antigen test) separated by greater than (>)24 hours. The second test should be within 72 hours of admission to the unit on Day -1.
  • Body mass index (BMI) within the range 18.5 to 24.9 kilograms per meter square (kg/m^2) (inclusive).

Who cannot join

  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
  • Active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed), or has required management of acute or chronic infections
  • History of any respiratory disease which (in the opinion of the investigator) would compromise participant safety or the ability of the participant to complete the study.
  • Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.
  • Current or previous active Tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extra pulmonary TB.
  • Previous close contact with a person with active TB and did not receive satisfactory anti-tuberculosis treatment as per World Health Organization (WHO) or national guidelines.
Show all 20Show fewer
  • Hemoglobin less than or equal to (<=)9 grams per deciliter (g/dL); white blood cell (WBC) count <=3.0 times 10^9/ Liter (L); platelet count <=100 times 10^9/L; absolute neutrophil count (ANC) <=1.0 times 10^9/L; lymphocyte count <=0.75 times 10^9/L at screening.
  • A vaccination (live or attenuated) within 30 days prior to Day 1 or Bacillus Calmette-Guerin (BCG) vaccination within 365 days prior to Day 1, or a live vaccination planned during the course of the study. Any COVID-19 vaccination within 14 days prior to enrolment.
  • Any surgical procedure, including bone or joint surgery/synovectomy within 8 weeks prior to Day 1 or any planned surgery within the duration of the study.
  • Significant allergies to humanized Monoclonal antibody (mAb).
  • Participants with known COVID-19 positive contacts within 14 days prior to screening.
  • History of lymphoma, leukemia, or any malignancy.
  • History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
  • Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the start of study intervention until completion of the evaluation visit, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
  • Treatment with biologic agents (such as mAb including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
  • Blood donation/sampling within 60 days prior to screening.
  • The participant with positive Serological test for syphilis, Human immunodeficiency virus (HIV) antigen/antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody.
  • The participant with positive test for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb), or Hepatitis C virus (HCV) antibody.
  • Positive pre-study drug/alcohol screen.
  • Participants with signs and symptoms suggestive of COVID-19 (fever, cough) within 14 days prior inpatient admission on Day -1.

About this study

Official title: A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.

Being tested
Otilimab
Keywords
Japanese participants, Otilimab, Pharmacokinetics, Rheumatoid arthritis, Safety, Tolerability
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • OtilimabBiological

    Otilimab will be administered via pre-filled syringe.

Study groups in NCT05304130
Study groupRoleWhat they receive
Healthy Japanese participants receiving otilimabExperimentalNot described
Receives: Biological: Otilimab

What is being measured

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

  1. Maximum drug concentration (Cmax) following administration of otilimab

    Measured: Up to 8 Weeks

  2. Area under the concentration-time curve from pre-dose to infinity (AUC[0-infinity]) following administration of otilimab

    Measured: Up to 8 Weeks

Secondary outcomes (26)

  1. Area under the plasma concentration-time curve from pre-dose to t (AUC[0-t]) following administration of otilimab

    Measured: Up to 8 Weeks

  2. Time to maximum plasma concentration (Tmax) following administration of otilimab

    Measured: Up to 8 Weeks

  3. Elimination half-life (t1/2) following administration of otilimab

    Measured: Up to 8 Weeks

  4. Time to reach the last quantifiable plasma concentration (Tlast) following administration of otilimab

    Measured: Up to 8 Weeks

  5. Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interests (AESIs)

    Measured: Up to 8 weeks

  6. Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter)

    Measured: Baseline and up to 8 weeks

  7. Change from Baseline in hematology parameter: Red blood cell (RBC) count (Trillion cells per liter)

    Measured: Baseline and up to 8 weeks

  8. Change from Baseline in hematology parameter: Hemoglobin (Grams per Liter)

    Measured: Baseline and up to 8 weeks

  9. Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)

    Measured: Baseline and up to 8 weeks

  10. Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)

    Measured: Baseline and up to 8 weeks

  11. Change from Baseline in hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms)

    Measured: Baseline and up to 8 weeks

  12. Change from Baseline in hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes)

    Measured: Baseline and up to 8 weeks

  13. Change from Baseline in clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), Creatine kinase, Gamma Glutamyl transferase (GGT), Lactate Dehydrogenase (International units per Liter)

    Measured: Baseline and up to 8 weeks

  14. Change from Baseline in clinical chemistry parameters: Calcium, glucose, potassium, sodium, Chloride, Phosphate and Blood urea nitrogen (BUN) (Millimoles per Liter)

    Measured: Baseline and up to 8 weeks

  15. Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin and uric acid (Micromoles per liter)

    Measured: Baseline and up to 8 weeks

  16. Change from Baseline in clinical chemistry parameters: Albumin and Total protein (Grams per liter)

    Measured: Baseline and up to 8 weeks

  17. Change from Baseline in clinical chemistry parameter: C-reactive protein (CRP) (Milligrams per liter

    Measured: Baseline and up to 8 weeks

  18. Change from Baseline in clinical chemistry parameter: Amylase (Units per liter)

    Measured: Baseline and up to 8 weeks

  19. Change from Baseline in lipid panel parameters: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides (Millimoles per Liter)

    Measured: Baseline and up to 8 weeks

  20. Number of participants with abnormal urinalysis parameters by Dipstick Method

    Measured: Baseline and up to 8 weeks

  21. Change from Baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury)

    Measured: Baseline and up to 8 weeks

  22. Change from Baseline in vital sign: Pulse rate (Beats per minute)

    Measured: Baseline and up to 8 weeks

  23. Change from Baseline in vital signs: Body temperature (Degrees Celsius)

    Measured: Baseline and up to 8 weeks

  24. Change from Baseline in Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds)

    Measured: Baseline and up to 8 weeks

  25. Number of participants with anti-drug antibodies (ADAs) to otilimab

    Measured: Up to Week 8

  26. Number of participants with drug-neutralizing antibodies to otilimab

    Measured: Up to Week 8

Timeline

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

  1. First posted31 Mar 2022
  2. Study start8 Feb 2023 (estimated)
  3. Primary completion4 May 2023 (estimated)
  4. Study completion4 May 2023 (estimated)

Why it stopped: This study was cancelled because of the limited efficacy demonstrated in the ContRAst phase III programme as a potential treatment for rheumatoid arthritis. GSK has decided not to progress with regulatory submissions

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Eligible participants will receive treatment with otilimab.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304130
Sponsor's protocol ID
208326
Status last verified
Jan 2023
First submitted
22 Mar 2022
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Otilimab in people with Arthritis, Rheumatoid, run by GlaxoSmithKline.

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 4 inclusion and 20 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: withdrawn, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximum drug concentration (Cmax) following administration of otilimab (time frame: Up to 8 Weeks). 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 NCT05304130.

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 26 Jan 2023.

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