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Cancer Vaccine

WP1302 400μg for Graves Disease

Phase 2
Recruiting
Research Sponsored by Worg Biotherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 65 years at the time of informed consent
Confirmed diagnosis of Graves' disease through medical history and/or physical examination, laboratory evidence as documented by a serum TSH<0.5 mU/L and either a serum total T3 >180 ng/dL or a serum free T4 > 1.8 ng/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial is testing the withdrawal of Methimazole in people with Graves' disease. Participants will go through different periods, including screening, treatment with Methimazole or placebo, tapering off Methim

Who is the study for?
This trial is for individuals with Graves' disease who are currently taking Methimazole. Participants must have stable thyroid levels to join and will be grouped based on the size of their goiter. People cannot participate if they don't meet specific health criteria that aren't listed here.Check my eligibility
What is being tested?
The study tests WP1302's ability to prevent relapse in Graves' disease after stopping Methimazole. It compares different doses of WP1302 (400, 800, or 1200 μg) against a placebo, alongside a tapering dose of Methimazole over several months.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions similar to other immune-modulating drugs such as fatigue, digestive issues, skin reactions, or potential impact on thyroid hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with Graves' disease, with specific thyroid hormone levels.
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I am a male either sterile or will use birth control during and 6 months after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 68 weeks including ltfu
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 weeks including ltfu for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relapse rate
Secondary outcome measures
Incidence of anti-drug antibodies (ADAs)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Pharmacokinetics (PK) parameters (AUC, Cmax)
+2 more
Other outcome measures
Cytokine levels of IFN-γ, IL-2, IL-6, and IL-10
HLA haplotypes
TSH receptor antibody (TRAb) levels
+1 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: WP1302 400μgActive Control2 Interventions
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
Group II: WP1302 800μgActive Control2 Interventions
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
Group III: WP1302 1200μgActive Control2 Interventions
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.
Group IV: WP1302 PlaceboPlacebo Group2 Interventions
After screening, eligible subjects will be randomized to treatment at a ratio (stratified by size of goiter [grade 0 or 1; grade 2], WHO classification) of 1:1:1:1 to either any group of MMI with WP1302 at a dose of 400 μg, 800 μg, or 1200 μg, or the group of MMI with placebo. The study consists of up to 5 periods: a screening period of up to 2 weeks; a WP1302 or placebo titration with MMI period of 12 weeks; a Full dose of WP1302 or placebo with MMI tapering period of 26 weeks; a follow-up period of 4 weeks; and an extended follow-up period of 6 months.

Find a Location

Who is running the clinical trial?

Worg Biotherapeutics Inc.Lead Sponsor
Dylan Lee, MDStudy ChairWorg Biotherapeutics Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the inclusion criteria for this research study open to individuals below 25 years of age?

"Enrollment is restricted to individuals over 18 years old but under the age of 65."

Answered by AI

Who is eligible to participate in this clinical study?

"Individuals diagnosed with Graves' disease aged between 18 and 65 are eligible for enrollment in this clinical trial, which has a capacity of admitting 176 participants."

Answered by AI

Are researchers currently enrolling participants for this medical study?

"Per clinicaltrials.gov, this investigation is actively seeking participants. Initial posting of the trial was on January 11th, 2024 and it underwent its latest update on January 25th, 2024."

Answered by AI

How large is the overall participant pool in this medical study?

"Indeed, the details on clinicaltrials.gov highlight that this investigation is actively seeking participants. The trial was initially published on January 11th, 2024 and last revised on January 25th, 2024. Enrollment of a total of 176 patients is planned at one designated site."

Answered by AI

Has the drug WP1302 400μg been granted approval by the FDA?

"Based on our evaluation at Power, the safety rating for WP1302 400μg is set at 2 due to its Phase 2 trial status. This suggests some evidence backing its safety profile but lacking data supporting efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz
2024. "Phase 2 Study to Assess Efficacy & Safety of WP1302 Prevent Relapse of MMI w/Draw in Subj. w/ Graves' dz". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06240455.
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~117 spots leftby May 2026
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