Progressive Multiple SclerosisPhase 1NCT02282826
A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
A Phase 1 study testing GZ402668 and acyclovir in people with Progressive Multiple Sclerosis, run by Genzyme, a Sanofi Company at 1 site in Germany.
Trial summary
Primary Objective: To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- GZ402668 and acyclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Mar 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, and progressive relapsing MS.
- Aged between 18 and 65 years, inclusive.
- Body weight greater than 40.0 kg.
- Female patient of child bearing potential must use 2 highly effective contraception methods.
- Male patient, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, 2 highly effective contraception methods. Male patient, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after investigational medicinal product administration.
- Male patient who has agreed not to donate sperm for 4 months after product administration.
Who cannot join
- Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency, autoimmune disease, renal failure, liver dysfunction, cancer (except treated basal skin cell carcinoma), or active infection.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day.
- If female, pregnancy, lactating, or breast-feeding.
- Patients with relapsing-remitting MS.
Show all 26Show fewer
- Lymphocyte counts below the lower limit of normal.
- Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months.
- Treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) in the last 12 months, or determined by the treating physician to have residual immune suppression from these treatments.
- Treatment with glatiramer acetate or interferon beta in the past 4 weeks.
- Treatment with fingolimod within the past 2 months.
- Treatment with dimethyl fumarate in past 4 weeks.
- Treatment with teriflunomide within the past 12 months unless patient has completed an accelerated clearance with cholestyramine.
- Previous treatment with alemtuzumab.
- Live, attenuated vaccine within 3 months prior to the randomization visit, such as varicella-zoster, oral polio, and rubella vaccines.
- Clinically significant abnormality in thyroid function.
- Inability to undergo magnetic resonance imaging with gadolinium administration.
- Hypersensitivity or contraindication to acyclovir.
- Known bleeding disorder.
- Significant autoimmune disease.
- Active infection or at high risk for infection.
- Latent or active tuberculosis.
- Major psychiatric disorder that is not adequately controlled by treatment.
- Epileptic seizures that are not adequately controlled by treatment.
- Prior history of invasive fungal infections.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis
Primary Objective:
To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess the following in men and women with progressive multiple sclerosis:
- The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.
- The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.
- The PK parameters of GZ402668 after ascending single SC doses.
- The PD of GZ402668 after ascending single SC doses.
Read the detailed description
The total study duration from screening for a patient can be approximately up to 8 weeks.
Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- GZ402668, placebo, acyclovir
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZ402668Drug
Pharmaceutical form:solution Route of administration: intravenous
placeboDrug
Pharmaceutical form:solution Route of administration: intravenous
GZ402668Drug
Pharmaceutical form:solution Route of administration: subcutaneous
placeboDrug
Pharmaceutical form:solution Route of administration: subcutaneous
acyclovirDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 IV | Experimental | GZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Dose 2 IV | Experimental | GZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Dose 3 IV | Experimental | GZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Dose 3 SC | Experimental | GZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Dose 4 SC | Experimental | GZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Dose 5 SC | Experimental | GZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: GZ402668; Drug: acyclovir |
| Placebo SC | Placebo comparator | placebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: placebo; Drug: acyclovir |
| Placebo IV | Placebo comparator | placebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy Receives: Drug: placebo; Drug: acyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events
Measured: 4 weeks
Secondary outcomes (6)
maximum concentration (Cmax)
Measured: 4 weeks
area under curve (AUC)
Measured: 4 weeks
Number of participants with lymphocyte depletion
Measured: 4 weeks
Number of participants with anti-drug antibodies
Measured: 4 weeks
Number of participants with injection site reactions
Measured: 2 weeks
Number of participants with corrected QT interval (QTcF) prolongation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionMar 2016
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 Progressive Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282826
- Sponsor's protocol ID
- TDU13475
- Other IDs
- 2014-001591-61, U1111-1155-6252, 2014
- Status last verified
- Apr 2016
- First submitted
- 31 Oct 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Albach FN, Geier C, Keicher C, Posch MG, Schreiber SJ, Grutz G, Akyuz L, Luo X, Le-Halpere A, Truffinet P, Wagner F. Phase 1 Trials of Gatralimab, a Next-Generation Humanized Anti-CD52 Monoclonal Antibody, in Participants with Progressive Multiple Sclerosis. Neurol Ther. 2024 Dec;13(6):1607-1625. doi: 10.1007/s40120-024-00659-w. Epub 2024 Sep 9.
PubMed 39251561
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Intravenous and Subcutaneous Doses of GZ402668 in Men and Women With Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02282826
- Acronym / sponsor ID
- TDU13475
- Conditions
- Progressive Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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.
Primary Objective:
To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and subcutaneous (SC) doses in men and women with progressive multiple sclerosis.
Secondary Objectives:
To assess the following in men and women with progressive multiple sclerosis:
- The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.
- The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.
- The PK parameters of GZ402668 after ascending single SC doses.
- The PD of GZ402668 after ascending single SC doses.
Detailed description
The total study duration from screening for a patient can be approximately up to 8 weeks.
Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a 4 year safety follow-up study for continued safety observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Dose 1 IV | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 1 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 2 IV | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 2 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 IV | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 3 intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 3 SC | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 3 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 4 SC | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 4 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Dose 5 SC | Experimental | Drug: GZ402668, Drug: acyclovirGZ402668 dose 5 subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo SC | Placebo comparator | Drug: placebo, Drug: acyclovirplacebo subcutaneous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
| Placebo IV | Placebo comparator | Drug: placebo, Drug: acyclovirplacebo intravenous, single administration. Acyclovir 200 mg twice daily for 28 days as prophylactic therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female adult with a diagnosis of progressive multiple sclerosis (MS) including primary progressive MS, secondary progressive MS, and progressive relapsing MS.
- Aged between 18 and 65 years, inclusive.
- Body weight greater than 40.0 kg.
- Female patient of child bearing potential must use 2 highly effective contraception methods.
- Male patient, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, 2 highly effective contraception methods. Male patient, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 4 months after investigational medicinal product administration.
Key exclusion criteria (26 listed)
- Significant medical diseases or conditions, including poorly controlled hypertension, cardiovascular disease, inflammatory disorders, immunodeficiency, autoimmune disease, renal failure, liver dysfunction, cancer (except treated basal skin cell carcinoma), or active infection.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
- History or presence of drug or alcohol abuse.
- Smoking more than 5 cigarettes or equivalent per day.
- If female, pregnancy, lactating, or breast-feeding.
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 |
|---|---|---|
| GZ402668Pharmaceutical form:solution Route of administration: intravenous | Drug | Dose 1 IV, Dose 2 IV, Dose 3 IV |
| placeboPharmaceutical form:solution Route of administration: intravenous | Drug | Placebo IV |
| GZ402668Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Dose 3 SC, Dose 4 SC, Dose 5 SC |
| placeboPharmaceutical form:solution Route of administration: subcutaneous | Drug | Placebo SC |
| acyclovirPharmaceutical form:tablet Route of administration: oral | Drug | Dose 1 IV, Dose 2 IV, Dose 3 IV, Dose 3 SC, Dose 4 SC, Dose 5 SC, Placebo IV, Placebo SC |
Primary outcome
Number of participants with treatment emergent adverse events
Time frame: 4 weeks
6 secondary outcomes
maximum concentration (Cmax)
Time frame: 4 weeks
area under curve (AUC)
Time frame: 4 weeks
Number of participants with lymphocyte depletion
Time frame: 4 weeks
Number of participants with anti-drug antibodies
Time frame: 4 weeks
Number of participants with injection site reactions
Time frame: 2 weeks
Number of participants with corrected QT interval (QTcF) prolongation
Time frame: 4 weeks
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 13 Apr 2016.
- Derived from this study: PubMed 39251561Albach FN, Geier C, Keicher C, Posch MG, Schreiber SJ, Grutz G, Akyuz L, Luo X, Le-Halpere A, Truffinet P, Wagner F. Phase 1 Trials of Gatralimab, a Next-Generation Humanized Anti-CD52 Monoclonal Antibody, in Participants with Progressive Multiple Sclerosis. Neurol Ther. 2024 Dec;13(6):1607-1625. doi: 10.1007/s40120-024-00659-w. Epub 2024 Sep 9.
Related trials for Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
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.
Clinical Sciences & Operations study director
Sanofi
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 GZ402668 and acyclovir in people with Progressive Multiple Sclerosis, run by Genzyme, a Sanofi Company at 1 site in Germany.
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 6 inclusion and 26 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 13 Apr 2016. 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 Germany. 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 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?
Number of participants with treatment emergent adverse events (time frame: 4 weeks). 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 NCT02282826, 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 13 Apr 2016.