A Randomized, Open-label, Placebo-Controlled, Parallel-Group Study to Evaluate the Immune System's Response to the Polyvalent Pneumococcal Vaccine (PNEUMOVAX 23) in Healthy Participants Receiving Intravenous Efgartigimod or Placebo.

Completed

Conditions: auto immune diseases
disease in which the immune system attacks its own body
10003816

Registration Number: NL-OMON50337

Lead Sponsor: Argenx BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

1. At least18 years of age at the time of signing the informed consent form
(ICF)
2. Healthy as determined by medical evaluation including medical history,
physical examination, laboratory tests, and cardiac monitoring
3. Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (inclusive)
4. Contraceptive use by men and women should be consistent with local
regulations regarding the methods of contraception for those participating in
clinical studies.
5. Capable of giving signed informed consent as described in Appendix 1,
Section 10.1.3, which includes compliance with the requirements and
restrictions listed in the ICF and in this protocol
6. Abstains from smoking for at least 3 months prior to screening
7. Negative urine drug screen (amphetamines, barbiturates, benzodiazepines,
cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at
screening and on day -1
8. Negative alcohol urine test at screening and on day -1
9. Agrees to restrict excessive strenuous physical activities 96 hours prior to
screening, 96 hours prior to the visits in the treatment period (D-1, D7, D14,
and D21), and 96 hours prior to the visits in follow-up period

Exclusion Criteria

1. Clinically significant active or chronic bacterial, viral, including or
fungal infection at day -1
2. History of malignancy unless deemed cured by adequate treatment with no
evidence of recurrence for >=3 years before the first administration of study
intervention. Participants with the following
cancers can be included at any time:
a. Adequately treated basal cell or squamous cell skin cancer
b. Carcinoma in situ of the cervix
c. Carcinoma in situ of the breast
d. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
3. Clinical evidence of other significant serious diseases, a recent major
surgery, or any other condition that, in the opinion of the investigator, could
confound the results of the study or put the participant at undue risk
4. Use of an investigational product within 2 months or 5 half-lives (whichever
is longer) before the first dose of study intervention
5. Use of any monoclonal antibody within 3 months prior to the initial study
intervention administration

For more exclusion criteria see the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the humoral immune response to the PNEUMOVAX 23 vaccine in healthy<br /><br>participants receiving efgartigimod intravenously (IV)</p><br>

Secondary Outcome Measures