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Cancer Vaccine

WP1302 for Graves' Disease

Phase 2

Waitlist Available

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

Must not have

Active thyroid eye disease (clinical activity score [CAS] ≥3) with functional visual impairment sufficient to cause poor quality of life, or dysthyroid optic neuropathy likely to require immunosuppressive treatment during the 30 weeks of the study

Prior use of disease-related T cell-inducing therapy or peptide-tolerizing agent to treat Graves' disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe thyroid eye disease affecting my vision and quality of life.

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I have used specific immune therapies for Graves' disease.

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My liver tests are more than three times the normal limit.

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I am currently taking biotin supplements.

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I am experiencing severe symptoms like fever, sweating, and jaundice due to an overactive thyroid.

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I do not have any active infections or conditions that weaken my immune system.

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I have a weak immune system due to a condition like HIV with low CD4 count, cancer, or after a bone marrow transplant.

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I have a known condition affecting my pituitary gland.

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I have had radioiodine treatment or thyroid surgery.

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I have had an overactive thyroid not due to Graves' disease.

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I have previously received immunotherapies or cytokine treatments.

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I have previously been treated with drugs that affect my immune system.

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I am currently undergoing some form of dialysis treatment.

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I have not had any cancer, other than skin cancer, in the last 5 years.

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I haven't had major surgery or needed ongoing treatment for it in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 68 weeks including ltfu

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse rate

Secondary study objectives

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 study objectives

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

Group III: WP1302 1200μgActive Control2 Interventions

Group IV: WP1302 PlaceboPlacebo Group2 Interventions

0 / 18Eligibility criteria met